Regulation (EC) No 304/2003 of the European Parliament and of the Coucil of 28 January 2003 concerning the export and import of dangerous chemicals (Text with EEA relevance)
304/2003 • 32003R0304
Legal Acts - Regulations
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Regulation (EC) No 304/2003 of the European Parliament and of the Coucil of 28 January 2003 concerning the export and import of dangerous chemicals (Text with EEA relevance) Official Journal L 063 , 06/03/2003 P. 0001 - 0026
Regulation (EC) No 304/2003 of the European Parliament and of the Coucil of 28 January 2003 concerning the export and import of dangerous chemicals (Text with EEA relevance) THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION, Having regard to the Treaty establishing the European Community, and in particular Article 175(1), thereof, Having regard to the proposal from the Commission(1), Having regard to the opinion of the European Economic and Social Committee(2), Having consulted the Committee of the Regions, Acting in accordance with the procedure laid down in Article 251 of the Treaty(3), Whereas: (1) Council Regulation (EEC) No 2455/92 of 23 July 1992 concerning the export and import of certain dangerous chemicals(4) establishes, inter alia, a common system of notification and information for exports to third countries of chemicals which are banned or severely restricted in the Community on account of their effects on human health and the environment. The Regulation applies on a mandatory basis the international "prior informed consent" (PIC) procedure under the non-binding provisions of the London Guidelines for the Exchange of Information on Chemicals in International Trade (London Guidelines) of the United Nations Environment Programme (UNEP), as amended in 1989, and under the International Code of Conduct on the Distribution and Use of Pesticides, as amended in 1990, of the Food and Agriculture Organisation (FAO). (2) On 11 September 1998, the Community signed the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade (the PIC Convention). At the same time, a Resolution on interim arrangements laid down in the Final Act of the Diplomatic Conference was adopted, setting up an interim PIC procedure based on the Convention text. (3) It is appropriate that the Community should act to implement the rules of the Convention, including, until such time as it enters into force, the interim PIC procedure, without in any way weakening the level of protection afforded to the environment and the general public of importing countries under Regulation (EEC) No 2455/92. (4) With the same objective in mind, it is also necessary and appropriate to go further than the provisions of the Convention in certain respects. Article 15(4) of the Convention allows Parties the right to take action that is more stringently protective of human health and the environment than that called for in the Convention, provided that such action is consistent with the provisions of the Convention and is in accordance with international law. (5) As regards the participation of the Community in the Convention, it is essential to have a single contact point for Community interaction with the Secretariat and other Parties to the Convention as well as with other countries. The Commission should act as this contact point. (6) Exports of dangerous chemicals that are banned or severely restricted within the Community should continue to be subject to a common export notification procedure. Accordingly, dangerous chemicals, whether in the form of a substance by itself or in a preparation, which have been banned or severely restricted by the Community as plant protection products, as other forms of pesticides, or as industrial chemicals for use by professional users or by the public, should be subject to similar export notification rules to those applicable to such chemicals when they are banned or severely restricted within either or both of the use categories laid down in the Convention, namely as pesticides or chemicals for industrial use. In addition, chemicals subject to the international PIC procedure should also be subject to the same rules. This export notification procedure should apply to Community exports to all third countries, whether or not they are Parties to the Convention or participate in its procedures. Member States should be permitted to charge administrative fees, in order to cover their costs in carrying out this procedure. (7) Exporters and importers should be obliged to provide information about the quantities of chemicals in international trade covered by this Regulation in order that the impact and effectiveness of the arrangements laid down therein can be monitored and assessed. (8) Notifications to the Secretariat of the Convention of Community or Member State regulatory actions banning or severely restricting chemicals, with a view to their inclusion in the international PIC procedure, should be submitted by the Commission and should relate to those cases meeting the criteria laid down in the Convention in this regard. Additional information to support such notifications should be sought where necessary. (9) In cases where Community or Member State regulatory actions do not qualify for notification because they do not meet the criteria, information about the actions should nevertheless be conveyed to the Convention Secretariat and other Parties to the Convention in the interests of information exchange. (10) It is also necessary to ensure that the Community takes decisions with regard to the import into the Community of chemicals that are subject to the international PIC procedure. These decisions should be based on applicable Community legislation and take into account bans or severe restrictions by Member States. Where justified, modifications of Community legislation should be prepared. (11) Arrangements are needed to ensure that Member States and exporters are aware of the decisions of importing countries as regards chemicals that are subject to the international PIC procedure, and that exporters comply with these decisions. Furthermore, in order to prevent undesired exports, for example because of failures by importing countries to provide such import decisions or to react to export notifications, no chemicals banned or severely restricted within the Community that meet the Convention criteria or that are covered under the international PIC procedure should be exported without the explicit consent of the importing country concerned, whether or not that country is a Party to the Convention. (12) It is also important that all exported chemicals have an adequate shelf-life so that they may be used effectively and safely. In particular as regards pesticides, and especially those exported to developing countries, it is essential that information about appropriate storage conditions is provided and that suitable packaging and sizes of containers are used to avoid creating obsolete stocks. (13) Articles containing chemicals do not fall within the scope of the Convention. Nevertheless, it seems appropriate that articles containing chemicals that could be released under conditions of use or disposal and that are banned or severely restricted in the Community within one or more of the use categories laid down in the Convention or are subject to the international PIC procedure should also be subject to the export notification rules. Furthermore, certain chemicals and articles containing specific chemicals falling outside the scope of the Convention but giving rise to particular concern should not be exported at all. Decisions as to which chemicals should be subject to such a strict control should be adopted by the Council by a qualified majority. (14) In accordance with the Convention, information on transit movements of chemicals subject to the international PIC procedure should be provided to Parties to the Convention requesting such information. (15) Community rules on packaging and labelling and other safety information should apply to all dangerous chemicals when intended for export to Parties and other countries unless these provisions would conflict with any specific requirements of those countries taking into account relevant international standards. (16) In order to ensure effective control and enforcement of the rules, the Member States should designate authorities such as customs authorities that should have the responsibility of controlling imports and exports of chemicals covered by this Regulation. The Commission and the Member States have a key role to play and should act in a targeted and coordinated way. Member States should provide for appropriate sanctions in the event of infringements. (17) Information exchange, shared responsibility and cooperative efforts between the Community and its Member States and third countries should be promoted with a view to ensuring sound management of chemicals, whether or not those third countries are Parties to the Convention. In particular, technical assistance to developing countries and countries with economies in transition should be provided directly by the Commission and the Member States, or indirectly via support for projects by non-governmental organisations (NGOs), especially assistance seeking to enable those countries to implement the Convention. (18) There should be regular monitoring of the operation of the procedures if they are to be effective. To this end, Member States should regularly submit reports to the Commission, which will in turn regularly report to the European Parliament and the Council. (19) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5). (20) In the light of the above, Regulation (EEC) No 2455/92 should be repealed and replaced, HAVE ADOPTED THIS REGULATION: Article 1 Objectives 1. The objectives of this Regulation are: (a) to implement the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade; (b) to promote shared responsibility and cooperative efforts in the international movement of hazardous chemicals in order to protect human health and the environment from potential harm; and (c) to contribute to their environmentally sound use. They shall be achieved by facilitating information exchange about the characteristics of such chemicals, by providing for a decision-making process within the Community on their import and export and by disseminating decisions to Parties and other countries as appropriate. 2. The objective of this Regulation is also to ensure that the provisions of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(6), and of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(7), regarding the classification, packaging and labelling of chemicals dangerous to man or to the environment when they are placed on the market in the European Community shall also apply to all such chemicals when they are exported from the Member States to other Parties or other countries, unless these provisions would conflict with any specific requirements of those Parties or other countries. Article 2 Scope 1. This Regulation applies to: (a) certain hazardous chemicals that are subject to the prior informed consent (PIC) procedure under the Rotterdam Convention; (b) certain hazardous chemicals that are banned or severely restricted within the Community or a Member State; and (c) all chemicals when exported insofar as their classification, packaging and labelling are concerned. 2. This Regulation shall not apply to: (a) narcotic drugs and psychotropic substances covered by Council Regulation (EEC) No 3677/90 of 13 December 1990 laying down measures to be taken to discourage the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic substances(8); (b) radioactive materials and substances covered by 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 ionizing radiation(9); (c) wastes covered by Council Directives 75/442/EEC of 15 July 1975 on waste(10) and 91/689/EEC of 12 December 1991 on hazardous waste(11); (d) chemical weapons covered by Council Regulation (EC) No 1334/2000 of 22 June 2000 setting up a Community regime for the control of exports of dual-use items and technology(12); (e) food and food additives covered by Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs(13); (f) feedingstuffs covered by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Agency and laying down procedures in matters of food safety(14) including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals; (g) genetically modified organisms as covered by Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC(15); (h) save to the extent covered by Article 3(4)(b), proprietary medicinal products and veterinary medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(16) and Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(17); (i) chemicals in quantities not likely to affect health or the environment, and in any event not more than 10 kg, provided that they are imported for the purpose of research or analysis. Article 3 Definitions For the purposes of this Regulation, the following definitions shall apply: 1. "chemical" means a substance as defined in Directive 67/548/EEC, whether by itself or in a preparation, or a preparation and whether manufactured or obtained from nature, but does not include living organisms. It consists of two categories: pesticides, including severely hazardous pesticide formulations; and industrial chemicals; 2. "preparation" means a mixture or a solution composed of two or more substances, if the preparation, as defined in Directive 1999/45/EC, is subject to compulsory labelling under Community legislation, on account of the presence of any of those substances; 3. "article" means a finished product containing or including a chemical, the use of which has been banned or severely restricted by Community legislation in that particular product; 4. "pesticides" means chemicals in either of the following two subcategories: (a) pesticides used as plant protection products as covered by Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(18); (b) other pesticides, such as biocidal products under 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(19) and such as disinfectants, insecticides and parasiticides under Directive 2001/82/EC and Directive 2001/83/EC; 5. "industrial chemicals" means chemicals in either of the following two subcategories: (a) chemicals for use by professionals; (b) chemicals for use by the public; 6. "chemical subject to export notification" means any chemical that is banned or severely restricted within the Community within one or more categories or subcategories, and any chemical that is subject to the PIC procedure listed in Part 1 of Annex I; 7. "chemical qualifying for PIC notification" means any chemical that is banned or severely restricted within the Community or a Member State within one or more categories. Chemicals banned or severely restricted in the Community within one or more categories are listed in Part 2 of Annex I; 8. "chemical subject to the PIC procedure" means any chemical listed in Annex III to the Convention or, before its entry into force, under the interim PIC procedure. These chemicals are listed in Part 3 of Annex I to this Regulation; 9. "banned chemical" means: (a) a chemical all uses of which within one or more categories or subcategories have been prohibited by final regulatory action by the Community, in order to protect human health or the environment; or (b) a chemical that has been refused approval for first-time use or has been withdrawn by industry either from the Community market or from further consideration in a notification, registration or approval process and where there is evidence that the chemical raises concerns for human health or the environment; 10. "severely restricted chemical" means: (a) a chemical, virtually all use of which within one or more categories or subcategories has been prohibited by final regulatory action in order to protect human health or the environment, but for which certain specific uses remain allowed; or (b) a chemical that has, for virtually all use, been refused for approval or been withdrawn by industry either from the Community market or from further consideration in a notification, registration or approval process, and where there is evidence that the chemical raises concern for human health or the environment; 11. "chemical banned or severely restricted by a Member State" means any chemical that is banned or severely restricted by national regulatory action of a Member State; 12. "final regulatory action" means a legislative act, the purpose of which is to ban or severely restrict a chemical; 13. "Convention" means the Rotterdam Convention of 10 September 1998 on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade; 14. "PIC procedure" means the Prior Informed Consent Procedure established by the Convention; 15. "severely hazardous pesticide formulation" means a chemical formulated for pesticidal use that produces severe health or environmental effects observable within a short period of time after single or multiple exposure, under conditions of use; 16. "export" means: (a) the permanent or temporary export of a chemical meeting the conditions of Article 23(2) of the Treaty; (b) the re-export of a chemical not meeting the conditions referred to in (a) which is placed under a customs procedure other than transit procedure; 17. "import" means the physical introduction into the customs territory of the Community of a chemical which is placed under a customs procedure other than transit procedure; 18. "exporter" means any natural or legal person on whose behalf an export declaration is made, that is to say the person who, at the time when the declaration is accepted, holds the contract with the consignee in a Party or other country and has the power for determining the sending of the chemical out of the customs territory of the Community. If no export contract has been concluded or if the holder of the contract does not act on its own behalf, the power for determining the sending of the chemical out of the customs territory of the Community shall be decisive; 19. "importer" means any natural or legal person who at the time of import into the customs territory of the Community is the consignee for the chemical; 20. "Party to the Convention" means a State or a regional economic integration organisation that has consented to be bound by the Convention and for which the Convention is in force; 21. "Party" means: (a) a Party to the Convention; (b) any country which has not ratified the Convention but which participates in the PIC procedure during a period to be established by the Conference of Parties; (c) before the entry into force of the Convention, any country participating in the interim PIC procedure established by the Resolution on interim arrangements adopted in Rotterdam on 11 September 1998; 22. "other country" means any country that is not a Party as defined in point 21; 23. "the Conference of the Parties" means the body established by Article 18 of the Convention to perform certain functions linked to implementation of the Convention; 24. "Chemical Review Committee" means the subsidiary body established by the Conference of the Parties in accordance with Article 18(6) of the Convention or, before its entry into force, the interim Chemical Review Committee established by the Resolution on interim arrangements; 25. "the Secretariat" means the Secretariat of the Convention or, before its entry into force, the interim Secretariat established by the Resolution on interim arrangements; 26. "decision guidance document" means the technical document prepared by the Chemical Review Committee for chemicals subject to the PIC procedure. Article 4 Designated national authorities Each Member State shall designate the authority or authorities, hereinafter referred to as the "designated national authority" or "designated national authorities", to act for the performance of the administrative functions required by this Regulation. It shall inform the Commission of such designation at the latest three months after the entry into force of this Regulation. Article 5 Participation of the Community in the Convention The participation of the Community in the Convention shall be a joint responsibility of the Commission and the Member States in particular for technical assistance, information exchange and matters relating to dispute settlement, participation in subsidiary bodies and voting. As far as the participation of the Community in the Convention is concerned, for the administrative functions of the Convention with reference to the PIC procedure and the export notification, the Commission shall act as a common designated authority on behalf of all the designated national authorities in close cooperation and consultation with the designated national authorities of the Member States. In particular, it shall be responsible for the transmission of Community export notifications to Parties and other countries pursuant to Article 7, the submission to the Secretariat of notifications of relevant final regulatory actions pursuant to Article 10, the transmission of information about other final regulatory actions not qualifying for PIC notification in accordance with Article 11, as well as for receiving information from the Secretariat more generally. The Commission shall also provide the Secretariat with Community import responses for chemicals subject to the PIC procedure pursuant to Article 12. In addition, the Commission shall coordinate the Community input on all technical issues related to the Convention, the preparation of the Conference of the Parties, the Chemical Review Committee and other subsidiary bodies. A network of Member State rapporteurs shall be established, as appropriate, to deal with the preparation of technical documents such as decision guidance documents. The Commission and the Member States shall take the necessary initiatives to ensure appropriate representation of the Community in the various bodies implementing the Convention. Article 6 Chemicals subject to export notification, qualifying for PIC notification, and subject to the PIC procedure 1. The chemicals covered by the provisions of this Regulation relating to export notification, PIC notification and the PIC procedure respectively shall be as listed in Annex I. 2. Chemicals in Annex I shall be assignable to one or more of three groups of chemicals, set out respectively as Parts 1, 2 and 3 of that Annex. The chemicals listed in Part 1 shall be subject to export notification as laid down in Article 7, with detailed information being given on the identity of the substance, on the use category and/or subcategory subject to restriction, the type of restriction and, where appropriate, additional information, in particular on exemptions to requirements for export notification. The chemicals listed in Part 2 shall, in addition to being subject to the export notification procedure under Article 7, qualify for the PIC notification procedure laid down in Article 10, with detailed information being given on the identity of the substance and on the use category. The chemicals listed in Part 3 shall be subject to the PIC procedure with the use category being given and, where appropriate, additional information, in particular on any requirements for export notification. 3. The lists shall be made available to the public by electronic means. Article 7 Export Notifications forwarded to Parties and other countries 1. When an exporter is due to export a chemical listed in Part 1 of Annex I from the Community to a Party or other country for the first time following the date as from which it becomes subject to the provisions of this Regulation, the exporter shall notify the designated national authority of the Member State in which he is established, no later than 30 days before the export of the chemical is due to take place. Thereafter the exporter shall notify the first export of the chemical each calendar year to the designated national authority no later than 15 days before the export of the chemical takes place. The notification shall comply with the requirements set out in Annex III. The designated national authority shall check compliance of the information with Annex III and promptly forward the notification received from the exporter to the Commission. The Commission shall take the necessary measures to ensure that the appropriate authorities of the importing Party or other country receive notification no later than 15 days prior to the first intended export of the chemical and thereafter before the first export of the chemical in any subsequent calendar year. This shall apply regardless of the expected use of the chemical in the importing Party or other country. Each export notification shall be registered in a database at the Commission and an updated list of the chemicals concerned and the importing Parties and other countries for each calendar year shall be kept available to the public, and distributed to the designated national authorities of the Member States as appropriate. 2. If the Commission does not receive from the importing Party or other country an acknowledgement of receipt of the first export notification made after the chemical is included in the Part 1 of Annex I within 30 days of the dispatch of the notification, it shall submit a second notification. The Commission shall make reasonable efforts to ensure that the appropriate authority in the importing Party or other country receives the second notification. 3. A new export notification as provided for in paragraph 1 shall be given for exports which take place subsequent to changes to Community legislation concerning the marketing, use or labelling of substances in question or whenever the composition of the preparation in question changes so that the labelling of such preparation is altered. The new notification shall comply with the requirements set out in Annex III and shall indicate that it is a revision of a previous notification. 4. Where the export of a chemical relates to an emergency situation in which any delay may endanger public health or the environment in the importing Party or other country, the provisions referred to above may be waived wholly or partly at the discretion of the designated national authority of the exporting Member State, in consultation with the Commission. 5. The obligations set out in paragraphs 1, 2 and 3 shall cease when: (a) the chemical has become a chemical subject to the PIC procedure; and (b) the importing country being a Party to the Convention has provided a response in accordance with Article 10(2) of the Convention to the Secretariat whether to consent or not to consent to import of the chemical; and (c) the Commission has received this information from the Secretariat and has forwarded it to Member States. That rule shall not apply where the importing country being Party to the Convention explicitly requires continued export notification by exporting Parties, for example through its import decision or otherwise. The obligations set out in paragraphs 1, 2 and 3 shall also cease when: (i) the appropriate authority of the importing Party or other country has waived the requirement to be notified before the export of the chemical; and (ii) the Commission has received the information from the Secretariat or from the appropriate authority of the importing Party or other country and has forwarded it to Member States and made it available on the Internet. 6. The Commission, the relevant designated national authorities of the Member States and the exporters shall provide importing Parties and other countries with available additional information on the exported chemicals, when requested. 7. Member States may establish systems obliging the exporter to pay an administrative fee for each export notification made, corresponding to their costs in carrying out the procedures associated with this Article. Article 8 Export notifications received from Parties and other countries 1. Export notifications received by the Commission from the designated national authority of a Party or another country concerning the export to the Community of a chemical the manufacture, use, handling, consumption, transport and/or sale of which is subject to prohibition or severe restriction under that Party's or other country's legislation shall be made available by electronic means through the database maintained by the Commission. The Commission shall acknowledge receipt of the first export notification received for each chemical from each Party or other country. The designated national authority of the Member State receiving that import shall receive a copy of any notification received together with all available information. Other Member States shall be entitled to receive copies on request. 2. Should the designated national authorities of the Member States receive any export notifications either directly or indirectly from the designated national authorities of Parties or relevant authorities of other countries, they shall immediately forward these notifications to the Commission together with all available information. Article 9 Information on trade in chemicals 1. Each exporter of a chemical listed in Annex I shall, during the first quarter each year, inform the designated national authority of its Member State on the quantity of the chemical (as a substance and as contained in preparations) shipped to each Party or other country during the preceding year. This information shall be given together with a list of the names and addresses of each importer to which shipment took place during the same period. Each importer within the Community shall provide the same information for the quantities imported into the Community. 2. Upon request from the Commission or the designated national authority, the exporter or importer shall provide any additional information relating to chemicals that is necessary to implement this Regulation. 3. Each Member State shall provide the Commission with aggregated information in accordance with Annex IV each year. The Commission shall summarise this information at Community level and shall make the non-confidential information publicly available on its database via the Internet. Article 10 Participation in the notification of banned or severely restricted chemicals under the Convention 1. Unless it has already done so prior to the entry into force of this Regulation, the Commission shall notify the Secretariat in writing of the chemicals that qualify for PIC notification. 2. As and when further chemicals qualify for PIC notification and are added to Part 2 of Annex I, the Commission shall notify the Secretariat. The notification shall be submitted as soon as possible after adoption of the relevant final Community regulatory action banning or severely restricting the chemical, and no later than 90 days after the date on which the final regulatory action is required to be applied. The notification shall provide all relevant information as required in Annex II. 3. In determining priorities for notifications, the Commission shall take into account whether the chemical is already listed in Part 3 of Annex I, the extent to which the information requirements laid down in Annex II can be met, and the severity of the risks presented by the chemical, in particular for developing countries. When a chemical qualifies for PIC notification, but the information is insufficient to meet the requirements of Annex II, identified exporters and/or importers shall, upon request by the Commission, provide all relevant information available to them, including that from other national or international chemical control programmes. 4. The Commission shall notify the Secretariat in writing when a final regulatory action notified under paragraphs 1 or 2 is modified as soon as possible after adoption of the new final regulatory action, and no later than 60 days after the date on which the new final regulatory action is required to be applied. It shall provide all relevant information that was not available at the time when the initial notification was made under paragraphs 1 or 2 respectively. 5. Upon request from any Party or from the Secretariat, the Commission shall provide additional information on the chemical or on the regulatory action, as far as practicable. The Member States shall, upon request, assist the Commission as necessary in compiling the information. 6. The Commission shall forward immediately to the Member States information that it receives from the Secretariat regarding chemicals notified as banned or severely restricted by other Parties. The Commission shall evaluate, in close cooperation with the Member States, the need to propose measures at Community level in order to prevent any unacceptable risks for human health and the environment within the Community. 7. In cases where a Member State takes national regulatory action in accordance with the relevant Community legislation to ban or severely restrict a chemical, it shall provide the Commission with relevant information. The Commission shall make this information available to the Member States. Within four weeks Member States may send comments on a possible PIC notification, including in particular relevant information about their national regulatory position in respect of the chemical, to the Commission and the Member State, which submitted a national regulatory action. After consideration of the comments the submitting Member State informs the Commission whether the latter shall: - notify the Secretariat, pursuant to this Article, or - provide the information to the Secretariat, pursuant to Article 11. Article 11 Information to be transmitted to the Secretariat about banned or severely restricted chemicals not qualifying for PIC notification When a chemical is listed only in Part 1 of Annex I or following receipt of information from a Member State for the purposes of Article 10(7), second indent, the Commission shall provide the Secretariat with information about the relevant regulatory actions, so that this information can be disseminated to other Parties to the Convention as appropriate. Article 12 Obligations in relation to imports of chemicals 1. The Commission shall forward immediately to the Member States decision guidance documents which it receives from the Secretariat. The Commission shall take an import decision, in the form of a final or interim import response on behalf of the Community, concerning the future import into the Community of the chemical concerned: it shall do so in accordance with existing Community legislation and the procedure referred to in Article 24(2). It shall then communicate the decision to the Secretariat as soon as possible, and no later than nine months after the date of dispatch of the decision guidance document by the Secretariat. If any chemical is subject to additional or modified restrictions under Community legislation, the Commission shall revise the import decision in accordance with the same procedure and communicate it to the Secretariat. 2. In the case of a chemical banned or severely restricted by the legislation of one or more Member States, the Commission shall, at the written request of the Member State(s) concerned, take the information into account in its import decision. 3. An import decision under paragraph 1 shall relate to the category or categories specified for the chemical in the decision guidance document. 4. When communicating the import decision to the Secretariat, the Commission shall provide a description of the legislative or administrative measure upon which it is based. 5. Each designated national authority within the Community shall make the import decisions under paragraph 1 available to those concerned within its competence, in accordance with its legislative or administrative measures. 6. Where appropriate, the Commission shall evaluate, in close cooperation with the Member States, the need to propose measures at Community level in order to prevent any unacceptable risks for human health and the environment within the Community, taking into account the information contained in the decision guidance document. Article 13 Obligations in relation to exports of chemicals other than export notification requirements 1. The Commission shall forward immediately to the Member States and European industry associations information which it receives, whether in the form of circulars or otherwise, from the Secretariat regarding chemicals subject to the PIC procedure and the decisions of importing Parties regarding import conditions on these chemicals. It shall also forward immediately to the Member States information on any cases of failure to transmit a response. The Commission shall keep all information regarding import decisions available in its database, which will be publicly available on the Internet, and provide anyone with the information upon request. 2. For each chemical listed in Annex I the Commission shall assign a classification in the European Community's Combined Nomenclature. These classifications shall be revised as necessary in the light of any changes made by the World Customs Organisation to the Harmonised System nomenclature for the chemicals concerned. 3. Each Member State shall communicate the responses forwarded by the Commission under paragraph 1 to those concerned within its jurisdiction. 4. Exporters shall comply with decisions in each import response no later than six months after the Secretariat has first informed the Commission of such response under paragraph 1. 5. The Commission and the Member States shall advise and assist importing Parties, upon request and as appropriate, to obtain further information to help them to make a response to the Secretariat concerning import of a given chemical. 6. No chemicals listed in the Parts 2 or 3 of Annex I shall be exported unless: (a) explicit consent to the import has been sought and received by the exporter through his designated national authority and the designated national authority of the importing Party or an appropriate authority in an importing other country; or (b) in the case of chemicals listed in Part 3 of Annex I, the latest circular issued by the Secretariat pursuant to paragraph 1 indicates that the importing Party has given consent to import. 7. No chemical shall be exported later than six months before the expiry date, when such a date exists or can be inferred from the production date, unless the intrinsic properties of the chemical render this impracticable. In particular, in the case of pesticides exporters shall ensure that the size and packaging of pesticide containers is optimised so as to minimise the risks of creating obsolete stocks. 8. When exporting pesticides, exporters shall ensure that the label contains specific information about storage conditions and storage stability under the climatic conditions of the importing Party or other country. In addition, they shall ensure that the exported pesticides comply with the purity specification established by Community legislation. Article 14 Controls on export of certain chemicals and articles containing chemicals 1. Articles containing chemicals listed in Parts 2 or 3 of Annex I in unreacted form shall be subject to the export notification procedure laid down in Article 7. 2. Chemicals and articles the use of which is prohibited in the Community for the protection of human health or the environment, as listed in Annex V, shall not be exported. Article 15 Information on transit movements 1. Parties to the Convention requiring information on transit movements of chemicals subject to the PIC procedure, together with the information requested by each Party to the Convention through the Secretariat, shall be as listed in Annex VI. 2. When a chemical listed in Part 3 of Annex I is transported through the territory of a Party to the Convention listed in Annex VI, the exporter shall, as far as practicable, provide the designated national authority of the Member State in which he is established with the information required by the Party to the Convention in accordance with Annex VI no later than 30 days before the first transit takes place and no later than eight days before each subsequent transit movement. 3. The designated national authority of the Member State shall forward to the Commission the information received from the exporter under paragraph 2 together with any available additional information. 4. The Commission shall forward the information received under paragraph 3 to the designated national authorities of Parties to the Convention which requested such information, together with any available additional information, no later than 15 days before first transit movement and prior to any subsequent transit movement. Article 16 Information to accompany exported chemicals 1. Chemicals that are intended for export shall be subject to the measures on packaging and labelling established in, or pursuant to, Directive 67/548/EEC, Directive 1999/45/EC, Directive 91/414/EEC and Directive 98/8/EC, or any other specific Community legislation. This obligation shall be without prejudice to any specific requirements of the importing Party or other country taking into account relevant international standards. 2. Where appropriate, the expiry date and the production date of chemicals referred to in paragraph 1 or listed in Annex I shall be indicated on the label, and if necessary such expiry dates shall be given for different climate zones. 3. A safety data sheet in accordance with Commission Directive 91/155/EEC(20) shall accompany chemicals referred to in paragraph 1, when exported. The exporter shall send such a safety data sheet to each importer. 4. The information on the label and on the safety data sheet shall as far as practicable be given in the official language(s), or in one or more of the principal languages, of the country of destination or of the area of intended use. Article 17 Obligations of the authorities of the Member States for controlling import and export Each Member State shall designate authorities such as customs authorities that shall have the responsibility of controlling the import and export of chemicals listed in Annex I. The Commission and the Member States shall act in a targeted and coordinated way in controlling compliance of exporters with this Regulation. Each Member State shall, in its regular reports on the operation of procedures pursuant to Article 21(1), include details of the activities of its authorities in this regard. Article 18 Penalties Member States shall determine the penalties applicable to infringements of the provisions of this Regulation and take all necessary measures to ensure correct implementation of these provisions. The penalties must be effective, proportional and dissuasive. Member States shall notify these measures to the Commission not later than 12 months after the adoption of this Regulation and shall also notify any further modifications as soon as possible after their adoption. Article 19 Information exchange 1. The Commission and the Member States shall, as appropriate, facilitate the provision of scientific, technical, economic and legal information concerning chemicals subject to this Regulation, including toxicological, ecotoxicological and safety information. The Commission, with the support of the Member States as necessary, shall, as appropriate, ensure: (a) the provision of publicly available information on regulatory actions relevant to the objectives of the Convention; and (b) the provision of information to Parties and other countries directly or through the Secretariat on those actions which substantially restrict one or more uses of a chemical. 2. The Commission and the Member States shall protect any confidential information received from another Party or another country as mutually agreed. 3. As regards the transmission of information under this Regulation, and without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment(21), the following shall not be regarded as confidential: (a) the information specified in Annex II and Annex III; (b) the information contained in safety data sheets referred to in paragraph 3 of Article 16; (c) the expiry date of the chemical; (d) the production date of the chemical; (e) information on precautionary measures, including hazard classification, the nature of the risk and the relevant safety advice; and (f) the summary results of the toxicological and ecotoxicological tests. A compilation of the information transmitted shall be prepared regularly by the Commission on the basis of the contributions of Member States. Article 20 Technical assistance The Commission and the designated national authorities of the Member States shall, taking into account in particular the needs of developing countries and countries with economies in transition, cooperate in promoting technical assistance, including training, for the development of the infrastructure, the capacity and the expertise necessary to manage chemicals properly throughout their life cycle. In particular, and with a view to enabling these countries to implement the Convention, technical assistance shall be promoted by providing technical information on chemicals, by promoting the exchange of experts, by giving support for the establishment or maintenance of designated national authorities and by providing technical expertise for the identification of hazardous pesticides formulations and for the preparation of notifications to the Secretariat. The Commission and the Member States should actively participate in the Information Network on Capacity Building set up by the Intergovernmental Forum on Chemical Safety, by providing information on the projects they are supporting or financing to improve the management of chemicals in developing countries and countries with economies in transition. The Commission and the Member States shall also consider giving support to non-governmental organisations. Article 21 Monitoring and reporting 1. Member States shall regularly forward to the Commission information on the operation of the procedures provided for in this Regulation, including customs controls, infringements, penalties, and remedial action. 2. The Commission shall regularly compile a report on the performance of the functions provided for in this Regulation for which it is responsible and shall integrate it in a synthesis report compiling the information provided by the Member States under paragraph 1. A summary of the report, which will be published on the Internet, shall be forwarded to the European Parliament and the Council. 3. As regards the information supplied pursuant to paragraphs 1 and 2, the Member States and the Commission shall comply with relevant obligations to protect the confidentiality of data and ownership. Article 22 Updating Annexes 1. The list of chemicals in Annex I shall be reviewed by the Commission at least every year, on the basis of developments under Community legislation and under the Convention. 2. In determining whether a final regulatory action under Community legislation constitutes a ban or a severe restriction, the effect of the action shall be assessed at the level of the subcategories within the categories "pesticides" and "industrial chemicals". If the regulatory action bans or severely restricts a chemical in any one of the subcategories it shall be included in the Part 1 of Annex I. In determining whether a final regulatory action under Community legislation constitutes a ban or a severe restriction such that the chemical concerned qualifies for PIC notification under Article 10, the effect of the action shall be assessed at the level of the categories "pesticides" and "industrial chemicals". If the regulatory action bans or severely restricts the use of a chemical within either of the categories it shall also be included in Part 2 of Annex I. 3. The Commission shall take a decision to include chemicals in Annex I, or to modify their entry where appropriate, without undue delay. 4. Inclusion of a chemical in the Parts 1 or 2 of Annex I pursuant to paragraph 2 following regulatory action under Community legislation shall be decided in accordance with the procedure referred to in Article 24(3). 5. All other amendments to Annex I, including modifications to existing entries, and amendments to Annexes II, III, IV and VI, shall be adopted by the procedure referred to in Article 24(2). Article 23 Technical notes for guidance The Commission, in accordance with the procedure referred to in Article 24(2), shall draw up technical notes for guidance to facilitate the day-to-day application of this Regulation. These technical notes shall be published in the C series of the Official Journal of the European Union. Article 24 Committee 1. The Commission shall be assisted by the Committee established by Article 29 of Directive 67/548/EEC. 2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. 3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof. The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months. 4. The Committee shall adopt its rules of procedure. Article 25 Repeal Regulation (EEC) No 2455/92 is hereby repealed. Article 26 Entry into force This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union. This Regulation shall be binding in its entirety and directly applicable in all Member States. Done at Brussels, 28 January 2003. For the European Parliament The President P. Cox For the Council The President G. Papandreou (1) OJ C 126 E, 28.5.2002, p. 291. (2) OJ C 241, 7.10.2002, p. 50. (3) Opinion of the European Parliament of 24 October 2002 (not yet published in the Official Journal) and Council Decision of 19 December 2002. (4) OJ L 251, 29.8.1992, p. 13. Regulation as last amended by Commission Regulation (EC) No 300/2002 (OJ L 52, 22.2.2002, p. 1). (5) OJ L 184, 17.7.1999, p. 23. (6) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1). (7) OJ L 200, 30.7.1999, p. 1. Directive as last amended by Commission Directive 2001/60/EC (OJ L 226, 22.8.2001, p. 5). (8) OJ L 357, 20.12.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1232/2002 (OJ L 180, 10.7.2002, p. 5). (9) OJ L 159, 29.6.1996, p. 1. (10) OJ L 194, 25.7.1975, p. 39. Directive as last amended by Commission Decision 96/350/EC (OJ L 135, 6.6.1996, p. 32). (11) OJ L 377, 31.12.1991, p. 20. Directive as last amended by Council Directive 94/31/EC (OJ L 168, 2.7.1994, p. 28). (12) OJ L 159, 30.6.2000, p. 1. Regulation as last amended by Council Regulation (EC) No 880/2002 (OJ L 139, 29.5.2002, p. 7). (13) OJ L 186, 30.6.1989, p. 23. Directive as last amended by Council Directive 93/99/EEC (OJ L 290, 24.11.1993, p. 14). (14) OJ L 31, 1.2.2002, p. 1. (15) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Council Decision 2002/811/EC (OJ L 280, 18.10.2002, p. 27). (16) OJ L 311, 28.11.2001, p. 67. (17) OJ L 311, 28.11.2001, p. 1. (18) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2002/81/EC (OJ L 276, 12.10.2002, p. 28). (19) OJ L 123, 24.4.1998, p. 1. (20) Commission Directive 91/155/EEC of 5 March 1991 defining and laying down detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Council Directive 88/379/EEC (OJ L 76, 22.3.1991, p. 35). Directive as last amended by Directive 2001/58/EC (OJ L 212, 7.8.2001, p. 24). (21) OJ L 158, 23.6.1990, p. 56. ANNEX I PART 1 List of chemicals subject to export notification procedure (Article 7 of this Regulation) It should be noted that where chemicals listed in this part of the Annex are subject to the PIC procedure, the export notification obligations set out in Article 7(1) to (3) of the Regulation shall not apply provided that the conditions laid down in Article 7(5)(b) and (c) have been fulfilled. Such chemicals, which are identified by the symbol >REFERENCE TO A GRAPHIC> in the list below, are listed again in Part 3 of this Annex for ease of reference. It should also be noted that where the chemicals listed in this part of the Annex qualify for PIC notification because of the nature of the Community's final regulatory action, these chemicals are also listed in Part 2 of this Annex. Such chemicals are identified by the symbol + in the list below. >TABLE> CAS = Chemical Abstracts Service. Chemical subject or partially subject to the PIC procedure. + Chemical qualifying for PIC notification. PART 2 List of chemicals qualifying for PIC notification (Article 10 of this Regulation) This list comprises chemicals qualifying for PIC notification. It generally does not include chemicals that are already subject to the PIC procedure, which are listed in Part 3 of this Annex. >TABLE> CAS = Chemical Abstracts Service. Chemical subject or partially subject to the international PIC procedure. PART 3 List of chemicals subject to the PIC procedure under the Rotterdam Convention (Articles 12 and 13 of this Regulation) (The categories shown are those referred to in the Convention) >TABLE> ANNEX II Notification of a banned or severely restricted chemical to the Secretariat of the Convention Information requirements for notifications pursuant to Article 10 of this Regulation Notifications shall include: 1. properties, identification and uses (a) common name; (b) chemical name according to an internationally recognised nomenclature (for example International Union of Pure and Applied Chemistry (IUPAC)), where such nomenclature exists; (c) trade names and names of preparations; (d) code numbers: Chemicals Abstract Service (CAS) number, Harmonised System Customs Code and other numbers; (e) information on hazard classification, where the chemical is subject to classification requirements; (f) use or uses of the chemical: in the European Union elsewhere (if known); (g) the physico-chemical, toxicological and ecotoxicological properties; 2. final regulatory action (a) information specific to the final regulatory action: (i) summary of the final regulatory action; (ii) reference to the regulatory document; (iii) date of entry into force of the final regulatory action; (iv) indication of whether the final regulatory action was taken on the basis of a risk or hazard evaluation and, if so, information on such an evaluation, covering a reference to the relevant documentation; (v) reasons for the final regulatory action relevant to human health, including the health of consumers and workers, or the environment; (vi) summary of the hazards and risks presented by the chemical to human health, including the health of consumers and workers, or the environment and the expected effect of the final regulatory action; (b) category or categories where the final regulatory action has been taken, and for each category: (i) use or uses prohibited by the final regulatory action; (ii) use or uses that remain allowed; (iii) estimation, where available, of quantities of the chemical produced, imported, exported and used; (c) an indication, to the extent possible, of the likely relevance of the final regulatory action to other States and regions; (d) other relevant information that may cover: (i) assessment of socio-economic effects of the final regulatory action; (ii) information on alternatives and their relative risks, where available, such as: - integrated pest management strategies, - industrial practices and processes, including cleaner technology. ANNEX III Export notification Information required pursuant to Article 7 of this Regulation 1. Identity of the substance to be exported: (a) name in nomenclature of the International Union of Pure and Applied Chemistry; (b) other names (usual names, trade names, and abbreviations); (c) Einecs number and CAS number; (d) CUS number and Combined Nomenclature Code; (e) main impurities of the substance, when particularly relevant. 2. Identity of the preparation to be exported: (a) trade name or designation of the preparation; (b) for each substance listed in Annex I, percentage and details as specified under item 1. 3. Information on the export: (a) country of destination; (b) country of origin; (c) expected date of first export this year; (d) intended use in the country of destination, if known; (e) name, address and other relevant particulars of the importer or importing company; (f) name, address and other relevant particulars of the exporter or exporting company. 4. Designated National Authorities: (a) name, address, telephone and telex, fax number or e-mail of the designated authority in the European Union from which further information may be obtained; (b) name, address, telephone and telex, fax number or e-mail of the designated authority in the importing country. 5. Information on precautions to be taken, including category of danger and risk and safety advice. 6. Summary on physico-chemical, toxicological and ecotoxicological properties. 7. Use of the chemical in the European Union: (a) uses, category(ies) under the Rotterdam Convention and Community subcategory(ies) subject to control measure (ban or severe restriction); (b) uses for which the chemical is not severely restricted or banned (use categories and subcategories as defined in Annex I of the Regulation); (c) estimation, where available, of quantities of the chemical produced, imported, exported and used. 8. Information on precautionary measures to reduce exposure to, and emission of, the chemical. 9. Summary of regulatory restrictions and reasons for them. Summary of information given in Annex II under point 2(a), (c) and (d). Additional information provided by the exporting Party because considered of concern or further information specified in Annex II when requested by the importing Party. ANNEX IV Information to be provided by the designated national authorities of the Member States to the Commission in accordance with Article 9 of this Regulation 1. Summary of quantities of chemicals (in the form of substances and preparations) subject to Annex I exported during the previous year. (a) Year in which exports took place (b) Table summarising quantities of exported chemicals (in the form of substances and preparations) as outlined below. >PIC FILE= "L_2003063EN.002402.TIF"> 2. List of importers >PIC FILE= "L_2003063EN.002403.TIF"> ANNEX V Chemicals and articles subject to export ban (Article 14 of this Regulation) >TABLE> ANNEX VI List of Parties to the Convention requiring information on transit movements of chemicals subject to the PIC procedure (Article 15 of this Regulation) >PIC FILE= "L_2003063EN.002602.TIF">
Regulation (EC) No 304/2003 of the European Parliament and of the Coucil
of 28 January 2003
concerning the export and import of dangerous chemicals
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Article 175(1), thereof,
Having regard to the proposal from the Commission(1),
Having regard to the opinion of the European Economic and Social Committee(2),
Having consulted the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty(3),
Whereas:
(1) Council Regulation (EEC) No 2455/92 of 23 July 1992 concerning the export and import of certain dangerous chemicals(4) establishes, inter alia, a common system of notification and information for exports to third countries of chemicals which are banned or severely restricted in the Community on account of their effects on human health and the environment. The Regulation applies on a mandatory basis the international "prior informed consent" (PIC) procedure under the non-binding provisions of the London Guidelines for the Exchange of Information on Chemicals in International Trade (London Guidelines) of the United Nations Environment Programme (UNEP), as amended in 1989, and under the International Code of Conduct on the Distribution and Use of Pesticides, as amended in 1990, of the Food and Agriculture Organisation (FAO).
(2) On 11 September 1998, the Community signed the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade (the PIC Convention). At the same time, a Resolution on interim arrangements laid down in the Final Act of the Diplomatic Conference was adopted, setting up an interim PIC procedure based on the Convention text.
(3) It is appropriate that the Community should act to implement the rules of the Convention, including, until such time as it enters into force, the interim PIC procedure, without in any way weakening the level of protection afforded to the environment and the general public of importing countries under Regulation (EEC) No 2455/92.
(4) With the same objective in mind, it is also necessary and appropriate to go further than the provisions of the Convention in certain respects. Article 15(4) of the Convention allows Parties the right to take action that is more stringently protective of human health and the environment than that called for in the Convention, provided that such action is consistent with the provisions of the Convention and is in accordance with international law.
(5) As regards the participation of the Community in the Convention, it is essential to have a single contact point for Community interaction with the Secretariat and other Parties to the Convention as well as with other countries. The Commission should act as this contact point.
(6) Exports of dangerous chemicals that are banned or severely restricted within the Community should continue to be subject to a common export notification procedure. Accordingly, dangerous chemicals, whether in the form of a substance by itself or in a preparation, which have been banned or severely restricted by the Community as plant protection products, as other forms of pesticides, or as industrial chemicals for use by professional users or by the public, should be subject to similar export notification rules to those applicable to such chemicals when they are banned or severely restricted within either or both of the use categories laid down in the Convention, namely as pesticides or chemicals for industrial use. In addition, chemicals subject to the international PIC procedure should also be subject to the same rules. This export notification procedure should apply to Community exports to all third countries, whether or not they are Parties to the Convention or participate in its procedures. Member States should be permitted to charge administrative fees, in order to cover their costs in carrying out this procedure.
(7) Exporters and importers should be obliged to provide information about the quantities of chemicals in international trade covered by this Regulation in order that the impact and effectiveness of the arrangements laid down therein can be monitored and assessed.
(8) Notifications to the Secretariat of the Convention of Community or Member State regulatory actions banning or severely restricting chemicals, with a view to their inclusion in the international PIC procedure, should be submitted by the Commission and should relate to those cases meeting the criteria laid down in the Convention in this regard. Additional information to support such notifications should be sought where necessary.
(9) In cases where Community or Member State regulatory actions do not qualify for notification because they do not meet the criteria, information about the actions should nevertheless be conveyed to the Convention Secretariat and other Parties to the Convention in the interests of information exchange.
(10) It is also necessary to ensure that the Community takes decisions with regard to the import into the Community of chemicals that are subject to the international PIC procedure. These decisions should be based on applicable Community legislation and take into account bans or severe restrictions by Member States. Where justified, modifications of Community legislation should be prepared.
(11) Arrangements are needed to ensure that Member States and exporters are aware of the decisions of importing countries as regards chemicals that are subject to the international PIC procedure, and that exporters comply with these decisions. Furthermore, in order to prevent undesired exports, for example because of failures by importing countries to provide such import decisions or to react to export notifications, no chemicals banned or severely restricted within the Community that meet the Convention criteria or that are covered under the international PIC procedure should be exported without the explicit consent of the importing country concerned, whether or not that country is a Party to the Convention.
(12) It is also important that all exported chemicals have an adequate shelf-life so that they may be used effectively and safely. In particular as regards pesticides, and especially those exported to developing countries, it is essential that information about appropriate storage conditions is provided and that suitable packaging and sizes of containers are used to avoid creating obsolete stocks.
(13) Articles containing chemicals do not fall within the scope of the Convention. Nevertheless, it seems appropriate that articles containing chemicals that could be released under conditions of use or disposal and that are banned or severely restricted in the Community within one or more of the use categories laid down in the Convention or are subject to the international PIC procedure should also be subject to the export notification rules. Furthermore, certain chemicals and articles containing specific chemicals falling outside the scope of the Convention but giving rise to particular concern should not be exported at all. Decisions as to which chemicals should be subject to such a strict control should be adopted by the Council by a qualified majority.
(14) In accordance with the Convention, information on transit movements of chemicals subject to the international PIC procedure should be provided to Parties to the Convention requesting such information.
(15) Community rules on packaging and labelling and other safety information should apply to all dangerous chemicals when intended for export to Parties and other countries unless these provisions would conflict with any specific requirements of those countries taking into account relevant international standards.
(16) In order to ensure effective control and enforcement of the rules, the Member States should designate authorities such as customs authorities that should have the responsibility of controlling imports and exports of chemicals covered by this Regulation. The Commission and the Member States have a key role to play and should act in a targeted and coordinated way. Member States should provide for appropriate sanctions in the event of infringements.
(17) Information exchange, shared responsibility and cooperative efforts between the Community and its Member States and third countries should be promoted with a view to ensuring sound management of chemicals, whether or not those third countries are Parties to the Convention. In particular, technical assistance to developing countries and countries with economies in transition should be provided directly by the Commission and the Member States, or indirectly via support for projects by non-governmental organisations (NGOs), especially assistance seeking to enable those countries to implement the Convention.
(18) There should be regular monitoring of the operation of the procedures if they are to be effective. To this end, Member States should regularly submit reports to the Commission, which will in turn regularly report to the European Parliament and the Council.
(19) The measures necessary for the implementation of this Regulation should be adopted in accordance with Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission(5).
(20) In the light of the above, Regulation (EEC) No 2455/92 should be repealed and replaced,
HAVE ADOPTED THIS REGULATION:
Article 1
Loading citations...Objectives
1. The objectives of this Regulation are:
(a) to implement the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade;
(b) to promote shared responsibility and cooperative efforts in the international movement of hazardous chemicals in order to protect human health and the environment from potential harm; and
(c) to contribute to their environmentally sound use.
They shall be achieved by facilitating information exchange about the characteristics of such chemicals, by providing for a decision-making process within the Community on their import and export and by disseminating decisions to Parties and other countries as appropriate.
2. The objective of this Regulation is also to ensure that the provisions of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances(6), and of Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations(7), regarding the classification, packaging and labelling of chemicals dangerous to man or to the environment when they are placed on the market in the European Community shall also apply to all such chemicals when they are exported from the Member States to other Parties or other countries, unless these provisions would conflict with any specific requirements of those Parties or other countries.
Article 2
Scope
1. This Regulation applies to:
(a) certain hazardous chemicals that are subject to the prior informed consent (PIC) procedure under the Rotterdam Convention;
(b) certain hazardous chemicals that are banned or severely restricted within the Community or a Member State; and
(c) all chemicals when exported insofar as their classification, packaging and labelling are concerned.
2. This Regulation shall not apply to:
(a) narcotic drugs and psychotropic substances covered by Council Regulation (EEC) No 3677/90 of 13 December 1990 laying down measures to be taken to discourage the diversion of certain substances to the illicit manufacture of narcotic drugs and psychotropic substances(8);
(b) radioactive materials and substances covered by 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 ionizing radiation(9);
(c) wastes covered by Council Directives 75/442/EEC of 15 July 1975 on waste(10) and 91/689/EEC of 12 December 1991 on hazardous waste(11);
(d) chemical weapons covered by Council Regulation (EC) No 1334/2000 of 22 June 2000 setting up a Community regime for the control of exports of dual-use items and technology(12);
(e) food and food additives covered by Council Directive 89/397/EEC of 14 June 1989 on the official control of foodstuffs(13);
(f) feedingstuffs covered by Regulation (EC) No 178/2002 of the European Parliament and of the Council of 28 January 2002 laying down the general principles and requirements of food law, establishing the European Food Safety Agency and laying down procedures in matters of food safety(14) including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;
(g) genetically modified organisms as covered by Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC(15);
(h) save to the extent covered by Article 3(4)(b), proprietary medicinal products and veterinary medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use(16) and Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products(17);
(i) chemicals in quantities not likely to affect health or the environment, and in any event not more than 10 kg, provided that they are imported for the purpose of research or analysis.
Article 3
Definitions
For the purposes of this Regulation, the following definitions shall apply:
1. "chemical" means a substance as defined in Directive 67/548/EEC, whether by itself or in a preparation, or a preparation and whether manufactured or obtained from nature, but does not include living organisms. It consists of two categories: pesticides, including severely hazardous pesticide formulations; and industrial chemicals;
2. "preparation" means a mixture or a solution composed of two or more substances, if the preparation, as defined in Directive 1999/45/EC, is subject to compulsory labelling under Community legislation, on account of the presence of any of those substances;
3. "article" means a finished product containing or including a chemical, the use of which has been banned or severely restricted by Community legislation in that particular product;
4. "pesticides" means chemicals in either of the following two subcategories:
(a) pesticides used as plant protection products as covered by Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market(18);
(b) other pesticides, such as biocidal products under 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(19) and such as disinfectants, insecticides and parasiticides under Directive 2001/82/EC and Directive 2001/83/EC;
5. "industrial chemicals" means chemicals in either of the following two subcategories:
(a) chemicals for use by professionals;
(b) chemicals for use by the public;
6. "chemical subject to export notification" means any chemical that is banned or severely restricted within the Community within one or more categories or subcategories, and any chemical that is subject to the PIC procedure listed in Part 1 of Annex I;
7. "chemical qualifying for PIC notification" means any chemical that is banned or severely restricted within the Community or a Member State within one or more categories. Chemicals banned or severely restricted in the Community within one or more categories are listed in Part 2 of Annex I;
8. "chemical subject to the PIC procedure" means any chemical listed in Annex III to the Convention or, before its entry into force, under the interim PIC procedure. These chemicals are listed in Part 3 of Annex I to this Regulation;
9. "banned chemical" means:
(a) a chemical all uses of which within one or more categories or subcategories have been prohibited by final regulatory action by the Community, in order to protect human health or the environment; or
(b) a chemical that has been refused approval for first-time use or has been withdrawn by industry either from the Community market or from further consideration in a notification, registration or approval process and where there is evidence that the chemical raises concerns for human health or the environment;
10. "severely restricted chemical" means:
(a) a chemical, virtually all use of which within one or more categories or subcategories has been prohibited by final regulatory action in order to protect human health or the environment, but for which certain specific uses remain allowed; or
(b) a chemical that has, for virtually all use, been refused for approval or been withdrawn by industry either from the Community market or from further consideration in a notification, registration or approval process, and where there is evidence that the chemical raises concern for human health or the environment;
11. "chemical banned or severely restricted by a Member State" means any chemical that is banned or severely restricted by national regulatory action of a Member State;
12. "final regulatory action" means a legislative act, the purpose of which is to ban or severely restrict a chemical;
13. "Convention" means the Rotterdam Convention of 10 September 1998 on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade;
14. "PIC procedure" means the Prior Informed Consent Procedure established by the Convention;
15. "severely hazardous pesticide formulation" means a chemical formulated for pesticidal use that produces severe health or environmental effects observable within a short period of time after single or multiple exposure, under conditions of use;
16. "export" means:
(a) the permanent or temporary export of a chemical meeting the conditions of Article 23(2) of the Treaty;
(b) the re-export of a chemical not meeting the conditions referred to in (a) which is placed under a customs procedure other than transit procedure;
17. "import" means the physical introduction into the customs territory of the Community of a chemical which is placed under a customs procedure other than transit procedure;
18. "exporter" means any natural or legal person on whose behalf an export declaration is made, that is to say the person who, at the time when the declaration is accepted, holds the contract with the consignee in a Party or other country and has the power for determining the sending of the chemical out of the customs territory of the Community. If no export contract has been concluded or if the holder of the contract does not act on its own behalf, the power for determining the sending of the chemical out of the customs territory of the Community shall be decisive;
19. "importer" means any natural or legal person who at the time of import into the customs territory of the Community is the consignee for the chemical;
20. "Party to the Convention" means a State or a regional economic integration organisation that has consented to be bound by the Convention and for which the Convention is in force;
21. "Party" means:
(a) a Party to the Convention;
(b) any country which has not ratified the Convention but which participates in the PIC procedure during a period to be established by the Conference of Parties;
(c) before the entry into force of the Convention, any country participating in the interim PIC procedure established by the Resolution on interim arrangements adopted in Rotterdam on 11 September 1998;
22. "other country" means any country that is not a Party as defined in point 21;
23. "the Conference of the Parties" means the body established by Article 18 of the Convention to perform certain functions linked to implementation of the Convention;
24. "Chemical Review Committee" means the subsidiary body established by the Conference of the Parties in accordance with Article 18(6) of the Convention or, before its entry into force, the interim Chemical Review Committee established by the Resolution on interim arrangements;
25. "the Secretariat" means the Secretariat of the Convention or, before its entry into force, the interim Secretariat established by the Resolution on interim arrangements;
26. "decision guidance document" means the technical document prepared by the Chemical Review Committee for chemicals subject to the PIC procedure.
Article 4
Designated national authorities
Each Member State shall designate the authority or authorities, hereinafter referred to as the "designated national authority" or "designated national authorities", to act for the performance of the administrative functions required by this Regulation.
It shall inform the Commission of such designation at the latest three months after the entry into force of this Regulation.
Article 5
Participation of the Community in the Convention
The participation of the Community in the Convention shall be a joint responsibility of the Commission and the Member States in particular for technical assistance, information exchange and matters relating to dispute settlement, participation in subsidiary bodies and voting.
As far as the participation of the Community in the Convention is concerned, for the administrative functions of the Convention with reference to the PIC procedure and the export notification, the Commission shall act as a common designated authority on behalf of all the designated national authorities in close cooperation and consultation with the designated national authorities of the Member States.
In particular, it shall be responsible for the transmission of Community export notifications to Parties and other countries pursuant to Article 7, the submission to the Secretariat of notifications of relevant final regulatory actions pursuant to Article 10, the transmission of information about other final regulatory actions not qualifying for PIC notification in accordance with Article 11, as well as for receiving information from the Secretariat more generally. The Commission shall also provide the Secretariat with Community import responses for chemicals subject to the PIC procedure pursuant to Article 12.
In addition, the Commission shall coordinate the Community input on all technical issues related to the Convention, the preparation of the Conference of the Parties, the Chemical Review Committee and other subsidiary bodies. A network of Member State rapporteurs shall be established, as appropriate, to deal with the preparation of technical documents such as decision guidance documents.
The Commission and the Member States shall take the necessary initiatives to ensure appropriate representation of the Community in the various bodies implementing the Convention.
Article 6
Chemicals subject to export notification, qualifying for PIC notification, and subject to the PIC procedure
1. The chemicals covered by the provisions of this Regulation relating to export notification, PIC notification and the PIC procedure respectively shall be as listed in Annex I.
2. Chemicals in Annex I shall be assignable to one or more of three groups of chemicals, set out respectively as Parts 1, 2 and 3 of that Annex.
The chemicals listed in Part 1 shall be subject to export notification as laid down in Article 7, with detailed information being given on the identity of the substance, on the use category and/or subcategory subject to restriction, the type of restriction and, where appropriate, additional information, in particular on exemptions to requirements for export notification.
The chemicals listed in Part 2 shall, in addition to being subject to the export notification procedure under Article 7, qualify for the PIC notification procedure laid down in Article 10, with detailed information being given on the identity of the substance and on the use category.
The chemicals listed in Part 3 shall be subject to the PIC procedure with the use category being given and, where appropriate, additional information, in particular on any requirements for export notification.
3. The lists shall be made available to the public by electronic means.
Article 7
Export Notifications forwarded to Parties and other countries
1. When an exporter is due to export a chemical listed in Part 1 of Annex I from the Community to a Party or other country for the first time following the date as from which it becomes subject to the provisions of this Regulation, the exporter shall notify the designated national authority of the Member State in which he is established, no later than 30 days before the export of the chemical is due to take place. Thereafter the exporter shall notify the first export of the chemical each calendar year to the designated national authority no later than 15 days before the export of the chemical takes place. The notification shall comply with the requirements set out in Annex III.
The designated national authority shall check compliance of the information with Annex III and promptly forward the notification received from the exporter to the Commission.
The Commission shall take the necessary measures to ensure that the appropriate authorities of the importing Party or other country receive notification no later than 15 days prior to the first intended export of the chemical and thereafter before the first export of the chemical in any subsequent calendar year. This shall apply regardless of the expected use of the chemical in the importing Party or other country.
Each export notification shall be registered in a database at the Commission and an updated list of the chemicals concerned and the importing Parties and other countries for each calendar year shall be kept available to the public, and distributed to the designated national authorities of the Member States as appropriate.
2. If the Commission does not receive from the importing Party or other country an acknowledgement of receipt of the first export notification made after the chemical is included in the Part 1 of Annex I within 30 days of the dispatch of the notification, it shall submit a second notification. The Commission shall make reasonable efforts to ensure that the appropriate authority in the importing Party or other country receives the second notification.
3. A new export notification as provided for in paragraph 1 shall be given for exports which take place subsequent to changes to Community legislation concerning the marketing, use or labelling of substances in question or whenever the composition of the preparation in question changes so that the labelling of such preparation is altered. The new notification shall comply with the requirements set out in Annex III and shall indicate that it is a revision of a previous notification.
4. Where the export of a chemical relates to an emergency situation in which any delay may endanger public health or the environment in the importing Party or other country, the provisions referred to above may be waived wholly or partly at the discretion of the designated national authority of the exporting Member State, in consultation with the Commission.
5. The obligations set out in paragraphs 1, 2 and 3 shall cease when:
(a) the chemical has become a chemical subject to the PIC procedure; and
(b) the importing country being a Party to the Convention has provided a response in accordance with Article 10(2) of the Convention to the Secretariat whether to consent or not to consent to import of the chemical; and
(c) the Commission has received this information from the Secretariat and has forwarded it to Member States.
That rule shall not apply where the importing country being Party to the Convention explicitly requires continued export notification by exporting Parties, for example through its import decision or otherwise.
The obligations set out in paragraphs 1, 2 and 3 shall also cease when:
(i) the appropriate authority of the importing Party or other country has waived the requirement to be notified before the export of the chemical; and
(ii) the Commission has received the information from the Secretariat or from the appropriate authority of the importing Party or other country and has forwarded it to Member States and made it available on the Internet.
6. The Commission, the relevant designated national authorities of the Member States and the exporters shall provide importing Parties and other countries with available additional information on the exported chemicals, when requested.
7. Member States may establish systems obliging the exporter to pay an administrative fee for each export notification made, corresponding to their costs in carrying out the procedures associated with this Article.
Article 8
Export notifications received from Parties and other countries
1. Export notifications received by the Commission from the designated national authority of a Party or another country concerning the export to the Community of a chemical the manufacture, use, handling, consumption, transport and/or sale of which is subject to prohibition or severe restriction under that Party's or other country's legislation shall be made available by electronic means through the database maintained by the Commission.
The Commission shall acknowledge receipt of the first export notification received for each chemical from each Party or other country.
The designated national authority of the Member State receiving that import shall receive a copy of any notification received together with all available information. Other Member States shall be entitled to receive copies on request.
2. Should the designated national authorities of the Member States receive any export notifications either directly or indirectly from the designated national authorities of Parties or relevant authorities of other countries, they shall immediately forward these notifications to the Commission together with all available information.
Article 9
Information on trade in chemicals
1. Each exporter of a chemical listed in Annex I shall, during the first quarter each year, inform the designated national authority of its Member State on the quantity of the chemical (as a substance and as contained in preparations) shipped to each Party or other country during the preceding year. This information shall be given together with a list of the names and addresses of each importer to which shipment took place during the same period.
Each importer within the Community shall provide the same information for the quantities imported into the Community.
2. Upon request from the Commission or the designated national authority, the exporter or importer shall provide any additional information relating to chemicals that is necessary to implement this Regulation.
3. Each Member State shall provide the Commission with aggregated information in accordance with Annex IV each year. The Commission shall summarise this information at Community level and shall make the non-confidential information publicly available on its database via the Internet.
Article 10
Participation in the notification of banned or severely restricted chemicals under the Convention
1. Unless it has already done so prior to the entry into force of this Regulation, the Commission shall notify the Secretariat in writing of the chemicals that qualify for PIC notification.
2. As and when further chemicals qualify for PIC notification and are added to Part 2 of Annex I, the Commission shall notify the Secretariat. The notification shall be submitted as soon as possible after adoption of the relevant final Community regulatory action banning or severely restricting the chemical, and no later than 90 days after the date on which the final regulatory action is required to be applied.
The notification shall provide all relevant information as required in Annex II.
3. In determining priorities for notifications, the Commission shall take into account whether the chemical is already listed in Part 3 of Annex I, the extent to which the information requirements laid down in Annex II can be met, and the severity of the risks presented by the chemical, in particular for developing countries.
When a chemical qualifies for PIC notification, but the information is insufficient to meet the requirements of Annex II, identified exporters and/or importers shall, upon request by the Commission, provide all relevant information available to them, including that from other national or international chemical control programmes.
4. The Commission shall notify the Secretariat in writing when a final regulatory action notified under paragraphs 1 or 2 is modified as soon as possible after adoption of the new final regulatory action, and no later than 60 days after the date on which the new final regulatory action is required to be applied.
It shall provide all relevant information that was not available at the time when the initial notification was made under paragraphs 1 or 2 respectively.
5. Upon request from any Party or from the Secretariat, the Commission shall provide additional information on the chemical or on the regulatory action, as far as practicable. The Member States shall, upon request, assist the Commission as necessary in compiling the information.
6. The Commission shall forward immediately to the Member States information that it receives from the Secretariat regarding chemicals notified as banned or severely restricted by other Parties.
The Commission shall evaluate, in close cooperation with the Member States, the need to propose measures at Community level in order to prevent any unacceptable risks for human health and the environment within the Community.
7. In cases where a Member State takes national regulatory action in accordance with the relevant Community legislation to ban or severely restrict a chemical, it shall provide the Commission with relevant information. The Commission shall make this information available to the Member States. Within four weeks Member States may send comments on a possible PIC notification, including in particular relevant information about their national regulatory position in respect of the chemical, to the Commission and the Member State, which submitted a national regulatory action. After consideration of the comments the submitting Member State informs the Commission whether the latter shall:
- notify the Secretariat, pursuant to this Article, or
- provide the information to the Secretariat, pursuant to Article 11.
Article 11
Information to be transmitted to the Secretariat about banned or severely restricted chemicals not qualifying for PIC notification
When a chemical is listed only in Part 1 of Annex I or following receipt of information from a Member State for the purposes of Article 10(7), second indent, the Commission shall provide the Secretariat with information about the relevant regulatory actions, so that this information can be disseminated to other Parties to the Convention as appropriate.
Article 12
Obligations in relation to imports of chemicals
1. The Commission shall forward immediately to the Member States decision guidance documents which it receives from the Secretariat. The Commission shall take an import decision, in the form of a final or interim import response on behalf of the Community, concerning the future import into the Community of the chemical concerned: it shall do so in accordance with existing Community legislation and the procedure referred to in Article 24(2). It shall then communicate the decision to the Secretariat as soon as possible, and no later than nine months after the date of dispatch of the decision guidance document by the Secretariat.
If any chemical is subject to additional or modified restrictions under Community legislation, the Commission shall revise the import decision in accordance with the same procedure and communicate it to the Secretariat.
2. In the case of a chemical banned or severely restricted by the legislation of one or more Member States, the Commission shall, at the written request of the Member State(s) concerned, take the information into account in its import decision.
3. An import decision under paragraph 1 shall relate to the category or categories specified for the chemical in the decision guidance document.
4. When communicating the import decision to the Secretariat, the Commission shall provide a description of the legislative or administrative measure upon which it is based.
5. Each designated national authority within the Community shall make the import decisions under paragraph 1 available to those concerned within its competence, in accordance with its legislative or administrative measures.
6. Where appropriate, the Commission shall evaluate, in close cooperation with the Member States, the need to propose measures at Community level in order to prevent any unacceptable risks for human health and the environment within the Community, taking into account the information contained in the decision guidance document.
Article 13
Obligations in relation to exports of chemicals other than export notification requirements
1. The Commission shall forward immediately to the Member States and European industry associations information which it receives, whether in the form of circulars or otherwise, from the Secretariat regarding chemicals subject to the PIC procedure and the decisions of importing Parties regarding import conditions on these chemicals. It shall also forward immediately to the Member States information on any cases of failure to transmit a response. The Commission shall keep all information regarding import decisions available in its database, which will be publicly available on the Internet, and provide anyone with the information upon request.
2. For each chemical listed in Annex I the Commission shall assign a classification in the European Community's Combined Nomenclature. These classifications shall be revised as necessary in the light of any changes made by the World Customs Organisation to the Harmonised System nomenclature for the chemicals concerned.
3. Each Member State shall communicate the responses forwarded by the Commission under paragraph 1 to those concerned within its jurisdiction.
4. Exporters shall comply with decisions in each import response no later than six months after the Secretariat has first informed the Commission of such response under paragraph 1.
5. The Commission and the Member States shall advise and assist importing Parties, upon request and as appropriate, to obtain further information to help them to make a response to the Secretariat concerning import of a given chemical.
6. No chemicals listed in the Parts 2 or 3 of Annex I shall be exported unless:
(a) explicit consent to the import has been sought and received by the exporter through his designated national authority and the designated national authority of the importing Party or an appropriate authority in an importing other country; or
(b) in the case of chemicals listed in Part 3 of Annex I, the latest circular issued by the Secretariat pursuant to paragraph 1 indicates that the importing Party has given consent to import.
7. No chemical shall be exported later than six months before the expiry date, when such a date exists or can be inferred from the production date, unless the intrinsic properties of the chemical render this impracticable. In particular, in the case of pesticides exporters shall ensure that the size and packaging of pesticide containers is optimised so as to minimise the risks of creating obsolete stocks.
8. When exporting pesticides, exporters shall ensure that the label contains specific information about storage conditions and storage stability under the climatic conditions of the importing Party or other country. In addition, they shall ensure that the exported pesticides comply with the purity specification established by Community legislation.
Article 14
Controls on export of certain chemicals and articles containing chemicals
1. Articles containing chemicals listed in Parts 2 or 3 of Annex I in unreacted form shall be subject to the export notification procedure laid down in Article 7.
2. Chemicals and articles the use of which is prohibited in the Community for the protection of human health or the environment, as listed in Annex V, shall not be exported.
Article 15
Information on transit movements
1. Parties to the Convention requiring information on transit movements of chemicals subject to the PIC procedure, together with the information requested by each Party to the Convention through the Secretariat, shall be as listed in Annex VI.
2. When a chemical listed in Part 3 of Annex I is transported through the territory of a Party to the Convention listed in Annex VI, the exporter shall, as far as practicable, provide the designated national authority of the Member State in which he is established with the information required by the Party to the Convention in accordance with Annex VI no later than 30 days before the first transit takes place and no later than eight days before each subsequent transit movement.
3. The designated national authority of the Member State shall forward to the Commission the information received from the exporter under paragraph 2 together with any available additional information.
4. The Commission shall forward the information received under paragraph 3 to the designated national authorities of Parties to the Convention which requested such information, together with any available additional information, no later than 15 days before first transit movement and prior to any subsequent transit movement.
Article 16
Information to accompany exported chemicals
1. Chemicals that are intended for export shall be subject to the measures on packaging and labelling established in, or pursuant to, Directive 67/548/EEC, Directive 1999/45/EC, Directive 91/414/EEC and Directive 98/8/EC, or any other specific Community legislation. This obligation shall be without prejudice to any specific requirements of the importing Party or other country taking into account relevant international standards.
2. Where appropriate, the expiry date and the production date of chemicals referred to in paragraph 1 or listed in Annex I shall be indicated on the label, and if necessary such expiry dates shall be given for different climate zones.
3. A safety data sheet in accordance with Commission Directive 91/155/EEC(20) shall accompany chemicals referred to in paragraph 1, when exported. The exporter shall send such a safety data sheet to each importer.
4. The information on the label and on the safety data sheet shall as far as practicable be given in the official language(s), or in one or more of the principal languages, of the country of destination or of the area of intended use.
Article 17
Obligations of the authorities of the Member States for controlling import and export
Each Member State shall designate authorities such as customs authorities that shall have the responsibility of controlling the import and export of chemicals listed in Annex I.
The Commission and the Member States shall act in a targeted and coordinated way in controlling compliance of exporters with this Regulation.
Each Member State shall, in its regular reports on the operation of procedures pursuant to Article 21(1), include details of the activities of its authorities in this regard.
Article 18
Penalties
Member States shall determine the penalties applicable to infringements of the provisions of this Regulation and take all necessary measures to ensure correct implementation of these provisions. The penalties must be effective, proportional and dissuasive. Member States shall notify these measures to the Commission not later than 12 months after the adoption of this Regulation and shall also notify any further modifications as soon as possible after their adoption.
Article 19
Information exchange
1. The Commission and the Member States shall, as appropriate, facilitate the provision of scientific, technical, economic and legal information concerning chemicals subject to this Regulation, including toxicological, ecotoxicological and safety information.
The Commission, with the support of the Member States as necessary, shall, as appropriate, ensure:
(a) the provision of publicly available information on regulatory actions relevant to the objectives of the Convention; and
(b) the provision of information to Parties and other countries directly or through the Secretariat on those actions which substantially restrict one or more uses of a chemical.
2. The Commission and the Member States shall protect any confidential information received from another Party or another country as mutually agreed.
3. As regards the transmission of information under this Regulation, and without prejudice to Council Directive 90/313/EEC of 7 June 1990 on the freedom of access to information on the environment(21), the following shall not be regarded as confidential:
(a) the information specified in Annex II and Annex III;
(b) the information contained in safety data sheets referred to in paragraph 3 of Article 16;
(c) the expiry date of the chemical;
(d) the production date of the chemical;
(e) information on precautionary measures, including hazard classification, the nature of the risk and the relevant safety advice; and
(f) the summary results of the toxicological and ecotoxicological tests.
A compilation of the information transmitted shall be prepared regularly by the Commission on the basis of the contributions of Member States.
Article 20
Technical assistance
The Commission and the designated national authorities of the Member States shall, taking into account in particular the needs of developing countries and countries with economies in transition, cooperate in promoting technical assistance, including training, for the development of the infrastructure, the capacity and the expertise necessary to manage chemicals properly throughout their life cycle.
In particular, and with a view to enabling these countries to implement the Convention, technical assistance shall be promoted by providing technical information on chemicals, by promoting the exchange of experts, by giving support for the establishment or maintenance of designated national authorities and by providing technical expertise for the identification of hazardous pesticides formulations and for the preparation of notifications to the Secretariat.
The Commission and the Member States should actively participate in the Information Network on Capacity Building set up by the Intergovernmental Forum on Chemical Safety, by providing information on the projects they are supporting or financing to improve the management of chemicals in developing countries and countries with economies in transition.
The Commission and the Member States shall also consider giving support to non-governmental organisations.
Article 21
Monitoring and reporting
1. Member States shall regularly forward to the Commission information on the operation of the procedures provided for in this Regulation, including customs controls, infringements, penalties, and remedial action.
2. The Commission shall regularly compile a report on the performance of the functions provided for in this Regulation for which it is responsible and shall integrate it in a synthesis report compiling the information provided by the Member States under paragraph 1. A summary of the report, which will be published on the Internet, shall be forwarded to the European Parliament and the Council.
3. As regards the information supplied pursuant to paragraphs 1 and 2, the Member States and the Commission shall comply with relevant obligations to protect the confidentiality of data and ownership.
Article 22
Updating Annexes
1. The list of chemicals in Annex I shall be reviewed by the Commission at least every year, on the basis of developments under Community legislation and under the Convention.
2. In determining whether a final regulatory action under Community legislation constitutes a ban or a severe restriction, the effect of the action shall be assessed at the level of the subcategories within the categories "pesticides" and "industrial chemicals". If the regulatory action bans or severely restricts a chemical in any one of the subcategories it shall be included in the Part 1 of Annex I.
In determining whether a final regulatory action under Community legislation constitutes a ban or a severe restriction such that the chemical concerned qualifies for PIC notification under Article 10, the effect of the action shall be assessed at the level of the categories "pesticides" and "industrial chemicals". If the regulatory action bans or severely restricts the use of a chemical within either of the categories it shall also be included in Part 2 of Annex I.
3. The Commission shall take a decision to include chemicals in Annex I, or to modify their entry where appropriate, without undue delay.
4. Inclusion of a chemical in the Parts 1 or 2 of Annex I pursuant to paragraph 2 following regulatory action under Community legislation shall be decided in accordance with the procedure referred to in Article 24(3).
5. All other amendments to Annex I, including modifications to existing entries, and amendments to Annexes II, III, IV and VI, shall be adopted by the procedure referred to in Article 24(2).
Article 23
Technical notes for guidance
The Commission, in accordance with the procedure referred to in Article 24(2), shall draw up technical notes for guidance to facilitate the day-to-day application of this Regulation.
These technical notes shall be published in the C series of the Official Journal of the European Union.
Article 24
Committee
1. The Commission shall be assisted by the Committee established by Article 29 of Directive 67/548/EEC.
2. Where reference is made to this paragraph, Articles 3 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
3. Where reference is made to this paragraph, Articles 5 and 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
The period laid down in Article 5(6) of Decision 1999/468/EC shall be set at three months.
4. The Committee shall adopt its rules of procedure.
Article 25
Repeal
Regulation (EEC) No 2455/92 is hereby repealed.
Article 26
Entry into force
This Regulation shall enter into force on the day following that of its publication in the Official Journal of the European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 28 January 2003.
For the European Parliament
The President
P. Cox
For the Council
The President
G. Papandreou
(1) OJ C 126 E, 28.5.2002, p. 291.
(2) OJ C 241, 7.10.2002, p. 50.
(3) Opinion of the European Parliament of 24 October 2002 (not yet published in the Official Journal) and Council Decision of 19 December 2002.
(4) OJ L 251, 29.8.1992, p. 13. Regulation as last amended by Commission Regulation (EC) No 300/2002 (OJ L 52, 22.2.2002, p. 1).
(5) OJ L 184, 17.7.1999, p. 23.
(6) OJ 196, 16.8.1967, p. 1. Directive as last amended by Commission Directive 2001/59/EC (OJ L 225, 21.8.2001, p. 1).
(7) OJ L 200, 30.7.1999, p. 1. Directive as last amended by Commission Directive 2001/60/EC (OJ L 226, 22.8.2001, p. 5).
(8) OJ L 357, 20.12.1990, p. 1. Regulation as last amended by Commission Regulation (EC) No 1232/2002 (OJ L 180, 10.7.2002, p. 5).
(9) OJ L 159, 29.6.1996, p. 1.
(10) OJ L 194, 25.7.1975, p. 39. Directive as last amended by Commission Decision 96/350/EC (OJ L 135, 6.6.1996, p. 32).
(11) OJ L 377, 31.12.1991, p. 20. Directive as last amended by Council Directive 94/31/EC (OJ L 168, 2.7.1994, p. 28).
(12) OJ L 159, 30.6.2000, p. 1. Regulation as last amended by Council Regulation (EC) No 880/2002 (OJ L 139, 29.5.2002, p. 7).
(13) OJ L 186, 30.6.1989, p. 23. Directive as last amended by Council Directive 93/99/EEC (OJ L 290, 24.11.1993, p. 14).
(14) OJ L 31, 1.2.2002, p. 1.
(15) OJ L 106, 17.4.2001, p. 1. Directive as last amended by Council Decision 2002/811/EC (OJ L 280, 18.10.2002, p. 27).
(16) OJ L 311, 28.11.2001, p. 67.
(17) OJ L 311, 28.11.2001, p. 1.
(18) OJ L 230, 19.8.1991, p. 1. Directive as last amended by Commission Directive 2002/81/EC (OJ L 276, 12.10.2002, p. 28).
(19) OJ L 123, 24.4.1998, p. 1.
(20) Commission Directive 91/155/EEC of 5 March 1991 defining and laying down detailed arrangements for the system of specific information relating to dangerous preparations in implementation of Article 10 of Council Directive 88/379/EEC (OJ L 76, 22.3.1991, p. 35). Directive as last amended by Directive 2001/58/EC (OJ L 212, 7.8.2001, p. 24).
(21) OJ L 158, 23.6.1990, p. 56.
ANNEX I
PART 1 List of chemicals subject to export notification procedure
(Article 7 of this Regulation)
It should be noted that where chemicals listed in this part of the Annex are subject to the PIC procedure, the export notification obligations set out in Article 7(1) to (3) of the Regulation shall not apply provided that the conditions laid down in Article 7(5)(b) and (c) have been fulfilled. Such chemicals, which are identified by the symbol >REFERENCE TO A GRAPHIC> in the list below, are listed again in Part 3 of this Annex for ease of reference.
It should also be noted that where the chemicals listed in this part of the Annex qualify for PIC notification because of the nature of the Community's final regulatory action, these chemicals are also listed in Part 2 of this Annex. Such chemicals are identified by the symbol + in the list below.
>TABLE>
CAS = Chemical Abstracts Service.
Chemical subject or partially subject to the PIC procedure.
+ Chemical qualifying for PIC notification.
PART 2 List of chemicals qualifying for PIC notification
(Article 10 of this Regulation)
This list comprises chemicals qualifying for PIC notification. It generally does not include chemicals that are already subject to the PIC procedure, which are listed in Part 3 of this Annex.
>TABLE>
CAS = Chemical Abstracts Service.
Chemical subject or partially subject to the international PIC procedure.
PART 3 List of chemicals subject to the PIC procedure under the Rotterdam Convention
(Articles 12 and 13 of this Regulation)
(The categories shown are those referred to in the Convention)
>TABLE>
ANNEX II
Notification of a banned or severely restricted chemical to the Secretariat of the Convention
Information requirements for notifications pursuant to Article 10 of this Regulation
Notifications shall include:
1. properties, identification and uses
(a) common name;
(b) chemical name according to an internationally recognised nomenclature (for example International Union of Pure and Applied Chemistry (IUPAC)), where such nomenclature exists;
(c) trade names and names of preparations;
(d) code numbers: Chemicals Abstract Service (CAS) number, Harmonised System Customs Code and other numbers;
(e) information on hazard classification, where the chemical is subject to classification requirements;
(f) use or uses of the chemical:
in the European Union
elsewhere (if known);
(g) the physico-chemical, toxicological and ecotoxicological properties;
2. final regulatory action
(a) information specific to the final regulatory action:
(i) summary of the final regulatory action;
(ii) reference to the regulatory document;
(iii) date of entry into force of the final regulatory action;
(iv) indication of whether the final regulatory action was taken on the basis of a risk or hazard evaluation and, if so, information on such an evaluation, covering a reference to the relevant documentation;
(v) reasons for the final regulatory action relevant to human health, including the health of consumers and workers, or the environment;
(vi) summary of the hazards and risks presented by the chemical to human health, including the health of consumers and workers, or the environment and the expected effect of the final regulatory action;
(b) category or categories where the final regulatory action has been taken, and for each category:
(i) use or uses prohibited by the final regulatory action;
(ii) use or uses that remain allowed;
(iii) estimation, where available, of quantities of the chemical produced, imported, exported and used;
(c) an indication, to the extent possible, of the likely relevance of the final regulatory action to other States and regions;
(d) other relevant information that may cover:
(i) assessment of socio-economic effects of the final regulatory action;
(ii) information on alternatives and their relative risks, where available, such as:
- integrated pest management strategies,
- industrial practices and processes, including cleaner technology.
ANNEX III
Export notification
Information required pursuant to Article 7 of this Regulation
1. Identity of the substance to be exported:
(a) name in nomenclature of the International Union of Pure and Applied Chemistry;
(b) other names (usual names, trade names, and abbreviations);
(c) Einecs number and CAS number;
(d) CUS number and Combined Nomenclature Code;
(e) main impurities of the substance, when particularly relevant.
2. Identity of the preparation to be exported:
(a) trade name or designation of the preparation;
(b) for each substance listed in Annex I, percentage and details as specified under item 1.
3. Information on the export:
(a) country of destination;
(b) country of origin;
(c) expected date of first export this year;
(d) intended use in the country of destination, if known;
(e) name, address and other relevant particulars of the importer or importing company;
(f) name, address and other relevant particulars of the exporter or exporting company.
4. Designated National Authorities:
(a) name, address, telephone and telex, fax number or e-mail of the designated authority in the European Union from which further information may be obtained;
(b) name, address, telephone and telex, fax number or e-mail of the designated authority in the importing country.
5. Information on precautions to be taken, including category of danger and risk and safety advice.
6. Summary on physico-chemical, toxicological and ecotoxicological properties.
7. Use of the chemical in the European Union:
(a) uses, category(ies) under the Rotterdam Convention and Community subcategory(ies) subject to control measure (ban or severe restriction);
(b) uses for which the chemical is not severely restricted or banned
(use categories and subcategories as defined in Annex I of the Regulation);
(c) estimation, where available, of quantities of the chemical produced, imported, exported and used.
8. Information on precautionary measures to reduce exposure to, and emission of, the chemical.
9. Summary of regulatory restrictions and reasons for them.
Summary of information given in Annex II under point 2(a), (c) and (d).
Additional information provided by the exporting Party because considered of concern or further information specified in Annex II when requested by the importing Party.
ANNEX IV
Information to be provided by the designated national authorities of the Member States to the Commission in accordance with Article 9 of this Regulation
1. Summary of quantities of chemicals (in the form of substances and preparations) subject to Annex I exported during the previous year.
(a) Year in which exports took place
(b) Table summarising quantities of exported chemicals (in the form of substances and preparations) as outlined below.
>PIC FILE= "L_2003063EN.002402.TIF">
2. List of importers
>PIC FILE= "L_2003063EN.002403.TIF">
ANNEX V
Chemicals and articles subject to export ban
(Article 14 of this Regulation)
>TABLE>
ANNEX VI
List of Parties to the Convention requiring information on transit movements of chemicals subject to the PIC procedure
(Article 15 of this Regulation)
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