REGULATION (EC) No 689/2008 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL
of 17 June 2008
concerning the export and import of dangerous chemicals
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and in particular Articles 133 and 175(1) thereof,
Having regard to the proposal from the Commission,
Having regard to the Opinion of the European Economic and Social Committee (1),
After consulting the Committee of the Regions,
Acting in accordance with the procedure laid down in Article 251 of the Treaty (2),
Whereas:
(1)
Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals (3) implemented the Rotterdam Convention on the prior informed consent procedure for certain hazardous chemicals and pesticides in international trade (4), hereinafter ‘the Convention’, which entered into force on 24 February 2004, and replaced Council Regulation (EEC) No 2455/92 of 23 July 1992 concerning the export and import of certain dangerous chemicals (5).
(2)
In its judgment of 10 January 2006 in Case C-178/03 (Commission v Parliament and Council) (6), the Court of Justice of the European Communities annulled Regulation (EC) No 304/2003 as it was based solely on Article 175(1) of the Treaty, ruling that both Articles 133 and 175(1) were the appropriate legal bases. However the Court also ruled that the effects of the Regulation were to be maintained until the adoption, within a reasonable period, of a new Regulation founded on appropriate legal bases. That also implies that obligations that were already fulfilled under Regulation (EC) No 304/2003 do not need to be accomplished again.
(3)
In accordance with Regulation (EC) No 304/2003, the Commission has submitted a report to the European Parliament and the Council on the operation of Regulation (EC) No 304/2003 from 2003 to 2005. Overall the procedures have worked well. However, the report identifies a number of technical amendments that appear to be necessary. It is therefore appropriate to incorporate those elements in this Regulation.
(4)
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. It is necessary and appropriate, in order not to weaken the level of protection afforded to the environment and to the general public of importing countries under Regulation (EEC) No 2455/92, to go further than the provisions of the Convention in certain respects.
(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 that 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 substances on their own or in preparations or in articles, 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 export notification rules similar 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 prior informed consent (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 concerning the quantities of chemicals in international trade covered by this Regulation so 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 final 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 final regulatory actions do not qualify for notification because they do not meet the criteria, information concerning 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 take 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 imposed by Member States. Where justified, amendments to Community legislation should be proposed.
(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 those decisions. Furthermore, in order to prevent undesired exports, 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 unless the explicit consent of the importing country concerned has been sought and obtained, whether or not that country is a Party to the Convention. At the same time, a waiver from this obligation is appropriate in relation to exports of certain chemicals to countries that are members of the Organisation for Economic Cooperation and Development (OECD) provided that certain conditions are met. Furthermore a procedure is needed to deal with cases in which, despite all reasonable efforts, no response is obtained from the importing country, so that exports of certain chemicals may proceed on a temporary basis under specified conditions. It is also necessary to provide for periodic review of all such cases as well as those in which explicit consent is obtained.
(12)
The database established by the Commission is an important tool which should underpin the application of this Regulation and its control.
(13)
It is also important that all chemicals exported have an adequate shelf-life so that they may be used effectively and safely. As regards pesticides, in particular and especially those exported to developing countries, it is essential that information about appropriate storage conditions be provided and that suitable packaging and sizes of containers are used to avoid creating obsolete stocks.
(14)
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 certain 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.
(15)
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 who request such information.
(16)
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 those provisions would conflict with any specific requirements of those countries, taking into account relevant international standards.
(17)
In order to ensure effective control and enforcement of the rules, 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. To facilitate customs control, and to reduce the administrative burden for both exporters and authorities, a system of codes confirming compliance with the rules to be used in export declarations should be established. In order to allow all parties time to become accustomed to this system before it becomes mandatory a short transitional period should be provided for.
(18)
Information exchange, shared responsibility and cooperative efforts between the Community and the 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, especially assistance seeking to enable those countries to implement the Convention.
(19)
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 should in turn regularly report to the European Parliament and the Council.
(20)
Technical notes for guidance should be drawn up to assist the competent authorities, including such authorities as customs controlling exports, in the application of this Regulation.
(21)
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 (7).
(22)
In particular the Commission should be empowered to adopt measures to include a chemical in Parts 1 or 2 of Annex I following final regulatory action at Community level, measures to include a chemical that is subject to Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants (8) in Part 1 of Annex V, measures to amend Annex I, including modifications to existing entries, measures to include a chemical already subject to an export ban at Community level in Part 2 of Annex V, measures to amend Annexes II, III, IV and VI, and measures to modify existing entries in Annex V. Since those measures are of general scope and are designed to amend non-essential elements of this Regulation, they must be adopted in accordance with the regulatory procedure with scrutiny provided for in Article 5a of Decision 1999/468/EC,
HAVE ADOPTED THIS REGULATION:
Article 1
Objectives
1. The objectives of this Regulation are the following:
(a)
to implement the Rotterdam Convention on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade, hereinafter ‘the Convention’;
(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;
(c)
to contribute to the environmentally sound use of hazardous chemicals.
The objectives referred to in the first subparagraph shall be achieved by facilitating the exchange of information concerning 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. In addition to the objectives referred to in paragraph 1, this Regulation shall ensure that the provisions of Council Directive 67/548/EEC (9) and of Directive 1999/45/EC of the European Parliament and of the Council (10) regarding the classification, packaging and labelling of chemicals dangerous to man or to the environment when they are placed on the market in the Community also apply to all such chemicals when they are exported from the Member States to other Parties or other countries, unless those provisions would conflict with any specific requirements of those Parties or other countries.
Article 2
Scope
1. This Regulation shall apply to the following:
(a)
certain hazardous chemicals that are subject to the prior informed consent procedure under the Convention, hereinafter ‘the PIC procedure’;
(b)
certain hazardous chemicals that are banned or severely restricted within the Community or a Member State;
(c)
chemicals when exported in so far as their classification, packaging and labelling are concerned.
2. This Regulation shall not apply to any of the following:
(a)
narcotic drugs and psychotropic substances covered by Council Regulation (EC) No 111/2005 of 22 December 2004 laying down rules for the monitoring of trade between the Community and third countries in drug precursors (11);
(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 (12);
(c)
wastes covered by Directive 2006/12/EC of the European Parliament and of the Council of 5 April 2006 on waste (13) and Council Directive 91/689/EEC of 12 December 1991 on hazardous waste (14);
(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 (15);
(e)
food and food additives covered by Regulation (EC) No 882/2004 of the European Parliament and of the Council of 29 April 2004 on official controls performed to ensure the verification of compliance with feed and food law, animal health and animal welfare rules (16);
(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 Authority and laying down procedures in matters of food safety (17) including additives, whether processed, partially processed or unprocessed, intended to be used for oral feeding to animals;
(g)
genetically modified organisms 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 (18);
(h)
save to the extent covered by Article 3(4)(b) of this Regulation, 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 (19) 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 (20);
(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 or exported 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, whether manufactured or obtained from nature, but does not include living organisms, which belongs to either of the following categories:
(a)
pesticides, including severely hazardous pesticide formulations;
(b)
industrial chemicals;
2.
‘preparation’ means a mixture or a solution composed of two or more 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 subcategories:
(a)
pesticides used as plant protection products covered by Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (21);
(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 (22) and such as disinfectants, insecticides and parasiticides covered by Directive 2001/82/EC and Directive 2001/83/EC;
5.
‘industrial chemicals’ means chemicals in either of the following 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 listed in Part 1 of Annex I that is subject to the PIC procedure;
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 and in Part 3 of Annex I to this Regulation;
9.
‘banned chemical’ means either of the following:
(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;
(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 concern for human health or the environment;
10.
‘severely restricted chemical’ means either of the following:
(a)
a chemical, virtually all use of which within one or more categories or subcategories has been prohibited by final regulatory action by the Community in order to protect human health or the environment, but for which certain specific uses remain allowed;
(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 final 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.
‘severely hazardous pesticide formulation’ means a chemical formulated for use as a pesticide that produces severe health or environmental effects observable within a short period of time after single or multiple exposure, under conditions of use;
14.
‘export’ means the following:
(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 of Article 23(2) of the Treaty which is placed under a customs procedure other than the external Community transit procedure for movement of goods through the customs territory of the Community;
15.
‘import’ means the physical introduction into the customs territory of the Community of a chemical that is placed under a customs procedure other than the external Community transit procedure for movement of goods through the customs territory of the Community;
16.
‘exporter’ means any of the following persons, whether natural or legal:
(a)
the 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 to determine that the chemical be sent out of the customs territory of the Community;
(b)
where no export contract has been concluded or where the holder of the contract does not act on its own behalf, the person who has the power to determine that the chemical be sent out of the customs territory of the Community;
(c)
where the benefit of a right to dispose of the chemical belongs to a person established outside the Community pursuant to the contract on which the export is based, the contracting party established in the Community;
17.
‘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;
18.
‘Party to the Convention’ or ‘Party’ 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;
19.
‘other country’ means any country that is not a Party.
Article 4
Designated national authorities
Each Member State shall designate the authority or authorities, hereinafter ‘the designated national authority’ or ‘the designated national authorities’, to carry out the administrative functions required by this Regulation, unless it has already done so before the entry into force of this Regulation.
It shall inform the Commission of such designation by 1 November 2008.
Article 5
Participation of the Community in the Convention
1. The participation of the Community in the Convention shall be a joint responsibility of the Commission and the Member States, in particular as regards technical assistance, the exchange of information and matters relating to dispute settlement, participation in subsidiary bodies and voting.
2. With regard to the Community's participation in the Convention, 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 and in close cooperation and consultation with all the designated national authorities of the Member States.
The Commission shall, in particular, be responsible for the following:
(a)
the transmission of Community export notifications to Parties and other countries pursuant to Article 7;
(b)
the submission to the Secretariat of the Convention, hereinafter ‘the Secretariat’, of notifications of relevant final regulatory actions concerning chemicals qualifying for PIC notification pursuant to Article 10;
(c)
the transmission of information concerning other final regulatory actions involving chemicals not qualifying for PIC notification in accordance with Article 11;
(d)
the receiving of 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 relating to any of the following:
(a)
the Convention;
(b)
the preparation of the Conference of the Parties established by Article 18 of the Convention;
(c)
the Chemical Review Committee established in accordance with Article 18(6) of the Convention;
(d)
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 as referred to in Article 7(3) of the Convention.
3. 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, chemicals qualifying for PIC notification, and chemicals 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 as Parts 1, 2 and 3 of Annex I.
The chemicals listed in Part 1 of Annex I shall be subject to the export notification procedure 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 of Annex I shall, in addition to being subject to the export notification procedure laid down in Article 7, qualify for the PIC notification procedure set out 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 of Annex I 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 referred to in paragraph 2 shall be made available to the public by electronic means.
Article 7
Export notifications forwarded to Parties and other countries
1. In the case of substances listed in Part 1 of Annex I or preparations containing such substances in a concentration that could trigger labelling obligations under Directive 1999/45/EC irrespective of the presence of any other substances, paragraphs 2 to 8 shall apply.
2. When an exporter is due to export a chemical referred to in paragraph 1 from the Community to a Party or other country for the first time on or after the date on which it becomes subject to 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 designated national authority of the first export of such chemical each calendar year no later than 15 days before the export takes place. The notification shall comply with the requirements set out in Annex II.
The designated national authority shall check compliance of the information with Annex II and promptly forward the notification received from the exporter to the Commission.
The Commission shall take the measures necessary to ensure that the designated national authority of the importing Party or the appropriate authority of the importing other country receive notification no later than 15 days before the first intended export of the chemical and thereafter before the first export 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 and assigned an export reference identification number 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.
3. If the Commission does not receive from the importing Party or other country an acknowledgement of receipt of the first export notification given after the chemical is included in the Part 1 of Annex I within 30 days of the dispatch of such notification, it shall submit a second notification. The Commission shall make reasonable efforts to ensure that the designated national authority of the importing Party or the appropriate authority of the importing other country receives the second notification.
4. A new export notification as provided for in paragraph 2 shall be given for exports which take place subsequent to changes to Community legislation concerning the marketing, use or labelling of the 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 II and shall indicate that it is a revision of a previous notification.
5. 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 requirements of paragraphs 2, 3 and 4 may be waived wholly or partly at the discretion of the designated national authority of the exporting Member State, in consultation with the Commission.
6. The obligations set out in paragraphs 2, 3 and 4 shall cease when the following conditions are fulfilled:
(a)
the chemical has become a chemical subject to the PIC procedure;
(b)
the importing country being a Party to the Convention has provided the Secretariat with a response in accordance with Article 10(2) of the Convention indicating whether or not it consents to import of the chemical;
(c)
the Commission has been informed of that response by the Secretariat and has forwarded that information to Member States.
The first subparagraph 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 2, 3 and 4 shall also cease when the following conditions are fulfilled:
(a)
the designated national authority of the importing Party or the appropriate authority of the importing other country has waived the requirement to be notified before the export of the chemical;
(b)
the Commission has received the information from the Secretariat or from the designated national authority of the importing Party or the appropriate authority of the importing other country and has forwarded it to Member States and made it available on the Internet.
7. 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 concerning the exported chemicals, when requested.
8. Member States may establish systems obliging exporters to pay an administrative fee for each export notification given and for each request for explicit consent made, corresponding to the costs to them of carrying out the procedures set out in paragraphs 2, 3 and 4 of this Article and in Article 13(3), (6) and (7).
Article 8
Export notifications received from Parties and other countries
1. Export notifications received by the Commission from the designated national authorities of Parties or the appropriate authorities of other countries concerning the export to the Community of a chemical the manufacture, use, handling, consumption, transport 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 the appropriate authorities of other countries, they shall immediately forward those notifications to the Commission together with all available information.
Article 9
Information on export and import of chemicals
1. Each exporter of:
-
substances listed in Annex I,
-
preparations containing such substances in a concentration that could trigger labelling obligations under Directive 1999/45/EC irrespective of the presence of any other substances, or
-
articles containing substances listed in Parts 2 or 3 of Annex I in unreacted form or preparations containing such substances in a concentration that could trigger labelling obligations under Directive 1999/45/EC irrespective of the presence of any other substances,
shall, during the first quarter of each year, inform the designated national authority of its Member State regarding the quantity of the chemical, as a substance and as contained in preparations or in articles, shipped to each Party or other country during the preceding year. That 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. That information shall list separately exports pursuant to Article 13(7).
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 of its Member State, 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 each year with aggregated information in accordance with Annex III. The Commission shall summarise that information at Community level and shall make the non-confidential information publicly available on its database via the Internet.
Article 10
Notification of banned or severely restricted chemicals under the Convention
1. The Commission shall notify the Secretariat in writing of the chemicals that qualify for PIC notification.
2. Where 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 must be applied.
3. The notification shall provide all relevant information as required in Annex IV.
4. 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 IV 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 IV, identified exporters 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, within 60 days of the request.
5. The Commission shall notify the Secretariat in writing when a final regulatory action notified under paragraphs 1 or 2 is amended 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 must be applied.
The Commission shall provide all relevant information that was not available at the time when the initial notification was given under paragraphs 1 or 2 respectively.
6. Upon request from any Party or from the Secretariat, the Commission shall provide additional information concerning the chemical or the final regulatory action, as far as practicable.
The Member States shall, upon request, assist the Commission as necessary in compiling that information.
7. 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.
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 to human health or the environment within the Community.
8. Where a Member State takes national final 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 that information available to the Member States. Within four weeks of that information having been made available 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 to the Member State which submitted the national final regulatory action. After consideration of the comments the submitting Member State shall inform 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 concerning 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 the second indent of Article 10(8), the Commission shall provide the Secretariat with information concerning the relevant final regulatory actions, so that that 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 immediately forward to the Member States any decision guidance documents which it receives from the Secretariat.
The Commission shall, in accordance with the advisory procedure referred to in Article 24(2), take an import decision, in the form of a final or interim import response on behalf of the Community, concerning the future import of the chemical concerned. 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.
Where a chemical is subject to additional or amended restrictions under Community legislation, the Commission shall revise the import decision in accordance with the advisory procedure referred to in Article 24(2) and communicate the revised import decision to the Secretariat.
2. In the case of a chemical banned or severely restricted by one or more Member States, the Commission shall, at the written request of the Member States 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 to human health or the environment within the Community, taking into account the information given in the decision guidance document.
Article 13
Obligations in relation to exports of chemicals other than export notification requirements
1. The Commission shall immediately forward 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 applicable to those chemicals. It shall also immediately forward to the Member States information concerning any cases of failure to transmit a response in accordance with Article 10(2) of the Convention. The Commission shall keep all information regarding import decisions, which shall each be assigned an import decision reference identification number, available in its database, which shall be publicly available on the Internet, and provide anyone with that information upon request.
2. The Commission shall assign each chemical listed in Annex I a classification in the European Community's Combined Nomenclature. Those classifications shall be revised as necessary in the light of any changes made in the World Customs Organization's Harmonized System Nomenclature or in the European Community's Combined 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 that 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. Substances listed in Parts 2 or 3 of Annex I or preparations containing such substances in a concentration that could trigger labelling obligations under Directive 1999/45/EC irrespective of the presence of any other substances shall not be exported unless either of the following conditions is fulfilled:
(a)
explicit consent to import has been sought and received by the exporter through his designated national authority in consultation with the Commission and the designated national authority of the importing Party or an appropriate authority in an importing other country;
(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.
In the case of chemicals listed in Part 2 of Annex I that are to be exported to OECD countries, the designated national authority of the exporter may, in consultation with the Commission and on a case-by-case basis, decide that no explicit consent is required if the chemical, at the time of importation into the OECD country concerned, is licensed, registered or authorised in that OECD country.
Where explicit consent has been sought pursuant to point (a), if the Commission or the designated national authority of the exporter has not received a response to its request within 30 days, the Commission shall send a reminder. Where appropriate, if there is still no response within a further 30 days, the Commission may send further reminders as necessary.
7. In the case of chemicals listed in Parts 2 or 3 of Annex I, the designated national authority of the exporter may, in consultation with the Commission and on a case-by-case basis, decide that the export may proceed if, after all reasonable efforts, no response to a request for explicit consent pursuant to paragraph 6(a) has been received within 60 days and there is evidence from official sources in the importing Party or other country that the chemical has been licensed, registered or authorised.
When deciding on the export of chemicals listed in Part 3 of Annex I, the designated national authority in consultation with the Commission shall consider the possible impact on human health or the environment of the use of the chemical in the importing Party or other country.
8. The validity of each explicit consent obtained pursuant to paragraph 6(a) or waiver granted pursuant to paragraph 7 shall be subject to periodic review by the Commission in consultation with the Member States concerned as follows:
(a)
for each explicit consent obtained pursuant to paragraph 6(a) a new explicit consent shall be required by the end of the third calendar year after the consent was given, unless the terms of that consent require otherwise;
(b)
unless a response to a request has been received in the meantime, each waiver granted pursuant to paragraph 7 shall be for a maximum period of 12 months, upon expiry of which explicit consent shall be required.
In the cases referred to in point (a) of this paragraph, exports may, however, continue after the end of the relevant period, pending a response to a new request for explicit consent, for an additional period of 12 months.
All new requests shall be channelled through the Commission.
9. The Commission shall register all requests for explicit consent, responses obtained and waivers granted in its database. Each explicit consent obtained or waived shall be assigned an explicit consent reference identification number and shall be listed with all relevant information concerning any conditions attached, validity dates, etc. The non-confidential information shall be made publicly available on the Internet.
10. No chemical shall be exported later than six months before its expiry date, when such a date exists or can be inferred from the production date, unless the intrinsic properties of the chemical render that impracticable. In particular, in the case of pesticides, exporters shall ensure that the size and packaging of containers is optimised so as to minimise the risks of creating obsolete stocks.
11. 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 pesticides exported comply with the purity specification laid down in Community legislation.
Article 14
Export of certain chemicals and articles containing chemicals
1. Articles containing substances listed in Parts 2 or 3 of Annex I in unreacted form or preparations containing such substances in a concentration that could trigger labelling obligations under Directive 1999/45/EC irrespective of the presence of any other substances 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 concerning 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 movement 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 additional information available.
4. The Commission shall forward the information received under paragraph 3 to the designated national authorities of Parties to the Convention which requested that information, together with any additional information available, no later than 15 days before the 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.
The first subparagraph 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 Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency (23) 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 languages, 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 and exporters for controlling imports and exports
1. 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, unless it has already done so before the entry into force of this Regulation.
The Commission and the Member States shall act in a targeted and coordinated way in monitoring exporters' compliance 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 that regard.
2. Exporters shall provide in their export declaration (box 44 of the Single Administrative Documents or corresponding data element in an electronic export declaration) as referred to in Article 161(5) of Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (24) the applicable reference identification numbers referred to in Article 7(2) or Article 13(1) or (9) of this Regulation as appropriate confirming compliance with the obligations to which they relate.
Article 18
Penalties
Member States shall determine the penalties applicable to infringements of the provisions of this Regulation and take all measures necessary to ensure correct implementation of these provisions. The penalties shall be effective, proportionate and dissuasive. If they have not already done so before the entry into force of this Regulation, Member States shall notify the Commission of those measures by 1 August 2009. They shall also notify it of any further modifications as soon as possible after their adoption.
Member States shall make all information regarding penalties available upon request.
Article 19
Exchange of information
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 concerning regulatory actions relevant to the objectives of the Convention; and
(b)
the provision of information for Parties and other countries directly or through the Secretariat concerning 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 a Party or other country as mutually agreed.
3. As regards the transmission of information under this Regulation, and without prejudice to Directive 2003/4/EC of the European Parliament and of the Council of 28 January 2003 on public access to environmental information (25), the following information at least shall not be regarded as confidential:
(a)
the information specified in Annex II and Annex IV;
(b)
the information contained in safety data sheets referred to in Article 16(3);
(c)
the expiry date of a chemical;
(d)
the production date of a chemical;
(e)
information concerning precautionary measures, including hazard classification, the nature of the risk and the relevant safety advice;
(f)
the summary results of toxicological and ecotoxicological tests;
(g)
information concerning handling packaging after chemicals have been removed.
A compilation of the information transmitted shall be prepared regularly by the Commission on the basis of the contributions by 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 lifecycles.
In particular, and with a view to enabling those countries to implement the Convention, technical assistance shall be promoted by means of the provision of technical information concerning chemicals, the promotion of the exchange of experts, support for the establishment or maintenance of designated national authorities and the provision of technical expertise for the identification of hazardous pesticide formulations and for the preparation of notifications to the Secretariat.
The Commission and the Member States shall actively participate in the Information Network on Capacity Building set up by the Intergovernmental Forum on Chemical Safety, by providing information concerning 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 concerning 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 incorporate it in a synthesis report integrating the information provided by the Member States under paragraph 1. A summary of that report, which shall be published on the Internet, shall be forwarded to the European Parliament and to 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 in Community law and under the Convention.
2. When determining whether a final regulatory action at Community level constitutes a ban or a severe restriction, the effect of that action shall be assessed at the level of the subcategories within the categories ‘pesticides’ and ‘industrial chemicals’. If the final regulatory action bans or severely restricts a chemical within any one of the subcategories it shall be included in Part 1 of Annex I.
When determining whether a final regulatory action at Community level constitutes a ban or a severe restriction such that the chemical concerned qualifies for PIC notification under Article 10, the effect of that action shall be assessed at the level of the categories ‘pesticides’ and ‘industrial chemicals’. If the final regulatory action bans or severely restricts a chemical within either of the categories it shall also be included in Part 2 of Annex I.
3. The decision to include chemicals in Annex I, or to amend their entry where appropriate, shall be taken without undue delay.
4. The following measures, designed to amend non-essential elements of this Regulation, shall be adopted in accordance with the regulatory procedure with scrutiny referred to in Article 24(3):
(a)
measures to include a chemical in Parts 1 or 2 of Annex I pursuant to paragraph 2 following final regulatory action at Community level;
(b)
measures to include a chemical that is subject to Regulation (EC) No 850/2004 in Part 1 of Annex V;
(c)
other measures to amend Annex I, including modifications to existing entries;
(d)
measures to include a chemical already subject to an export ban at Community level in Part 2 of Annex V;
(e)
measures to amend Annexes II, III, IV and VI;
(f)
measures to modify existing entries in Annex V.
Article 23
Technical notes for guidance
The Commission, in accordance with the advisory procedure referred to in Article 24(2), shall draw up technical notes for guidance to facilitate the day-to-day application of this Regulation.
The 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 133 of Regulation (EC) No 1907/2006.
2. Where reference is made to this paragraph, Article 3 and Article 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, Article 5(a)(1) to (4) and Article 7 of Decision 1999/468/EC shall apply, having regard to the provisions of Article 8 thereof.
Article 25
References to Regulation (EC) No 304/2003
References to Regulation (EC) No 304/2003 shall be construed as references to this Regulation.
Article 26
Entry into force
This Regulation shall enter into force on the day following its publication in the Official Journal of the European Union.
Article 17(2), however, shall apply as from 1 November 2008.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Strasbourg, 17 June 2008.