Proposal for a COUNCIL REGULATION concerning the export and import of dangerous chemicals

(presented by the Commission)

EXPLANATORY MEMORANDUM

1. Introduction

In 1998 the Rotterdam Convention for the application of the Prior Informed Consent (PIC) procedure for certain hazardous chemicals and pesticides in international trade was concluded. It was signed by the European Community on 11 September 1998. The Convention will enter into force on the ninetieth day after the date of deposit of the fiftieth instrument of ratification, acceptance, approval or accession.

The purpose of the proposed Regulation is to give effect to the provisions of the Convention within the Community. A separate proposal for a Council decision concerning the Community's ratification of the Convention is being submitted in parallel to the present proposal.

2. The Convention

The Convention is an important step in improving international regulation of hazardous chemicals. Its aim is to promote shared responsibility and co-operative efforts among the Parties in the international trade of such chemicals in order to protect human health and the environment from potential harm and to contribute to their environmentally sound use.

It is mainly based on the non-legally binding provisions of the London Guidelines for the Exchange of Information on Chemicals in International Trade of the United Nations Environment Programme (UNEP), as amended in 1989, and on the International Code of Conduct on the Distribution and Use of Pesticides, as amended in 1990, of the Food and Agriculture Organisation (FAO). Those provisions provided for a voluntary PIC procedure, which is already being applied on a voluntary basis by more than 160 countries. The European Community has participated in these arrangements and made the voluntary procedure legally binding through Council Regulation (EEC) No 2455/92 (see below). In accordance with the resolution on interim arrangements adopted by the September 1998 Ministerial Conference when the Convention was opened for signature, the previous voluntary procedures, modified as necessary, have been subsumed in those interim arrangements so that the Convention rules can be applied voluntarily in advance of entry into force. The European Community is participating fully in this transitional system.

The Convention covers chemical substances (as a substance in itself or in a mixture or preparation) in the form of pesticides (including severely hazardous pesticide formulations) and industrial chemicals that have been banned or severely restricted by final governmental regulatory action for health or environmental reasons. Certain specific groups of chemicals such as radioactive materials, wastes, pharmaceuticals, food and food additives are excluded from its scope. Also excluded are chemicals in small quantities for research or analysis purposes or for personal use by an individual.

The basic principle of the Convention is that the export of a banned or severely restricted chemical which is included in Annex III to the Convention can only take place with the PIC of the importing Party. A procedure is established for formally obtaining and making known the decisions of importing countries as to whether they wish to receive future shipments of a certain chemical and for ensuring compliance with these decisions by exporting countries. Currently 31 chemicals are subject to the PIC procedure. The Convention establishes a mechanism for including further substances, provided that certain criteria are met.

The trigger for inclusion of a chemical in the process is that Parties must notify the Secretariat of all final regulatory actions banning or severely restricting a chemical falling within the scope of the Convention. After notifications from at least two Parties belonging to different geographic regions defined by the Conference of the Parties (CoP) under the Convention have been submitted to the Secretariat, the information will be evaluated by a subsidiary body, the Chemical Review Committee (CRC), composed of government-designated experts in chemicals management. If the relevant criteria are met, the CRC drafts a decision guidance document and recommends to the CoP that the chemical be included in the PIC procedure. The CoP then decides whether or not the chemical will be so included. The decision guidance document is then circulated to all Parties providing information to enable them to take an informed decision whether to accept or refuse import, or to allow import under certain conditions. Every six months the Secretariat informs all Parties of the responses received (the so-called "PIC circulars"). Exporting parties are obliged to ensure that their exporters comply with any import decisions.

The other key pillar of the Convention relates to the exchange of information among Parties about potentially hazardous chemicals that may be exported and imported.

The main provision in this regard is the requirement that a Party that plans to export a chemical that is banned or severely restricted for use within its territory, must inform the importing Party that such export will take place, before the first shipment and annually thereafter (the so-called "export notification" procedure) until the chemical becomes subject to the PIC procedure and the importing party has provided an import response for the chemical which has been distributed to the Parties. In addition, the exporting Party must require that exports of chemicals included in the PIC procedure are subject to labelling requirements that ensure adequate availability of information with regard to risks and/or hazards to human health or the environment. It may also impose similar requirements for exports of other chemicals that are banned or severely restricted domestically.

The Convention also contains provisions relating to technical assistance between Parties. Parties with more advanced programmes for regulating chemicals should provide technical assistance, including training, to others such as developing countries to help them develop their infrastructure and capacity to manage chemicals.

As of 1 September 2001, there were 73 signatories to the Convention and 16 countries had ratified. On present forecasts, it is expected to enter into force by 2003.

3. Existing Community rules

The current Community rules relating to the export and import of certain dangerous chemicals are laid down in Council Regulation (EEC) No 2455/92 [1], as most recently amended by Commission Regulation (EC) No 2247/98 [2], hereinafter referred to as Regulation (EEC) No 2455/92.

[1] OJ L 251, 29.8.1992, p. 13.

[2] OJ L 282, 20.10.1998, p. 12.

Regulation (EEC) No 2455/92 has three main objectives:

- to apply a common export notification system 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 (this is based on a single notification to the importing country, followed up with a system of Export Reference numbers, which must accompany the first and any subsequent shipments);

- to apply and make mandatory in the Community the UNEP/FAO voluntary PIC procedure for imports from and exports to third countries of those chemicals subject to the PIC arrangements;

- to ensure that dangerous chemicals and preparations exported to third countries are labelled and packaged in the same way as they must be within the Community.

4. Anticipation of certain provisions of the Convention

The European Chemical Industry Council (CEFIC) and the European Association of Chemical Distributors (FECC) have taken an initiative unilaterally to apply certain provisions of the Convention on a voluntary basis prior to its entry into force. Under this initiative, the Convention's rules on export notification would be implemented with certain adaptations. This commitment is without prejudice to the rules laid down in Regulation (EEC) No 2455/92 and will cease when this proposed Regulation comes into force.

The voluntary arrangements came into operation on 1 April 2001.

5. Proposed new rules

Reasons and Objectives

The proposed Council Regulation would implement the Convention and replace Council Regulation (EEC) No 2455/92, which would be revoked.

Since the latter Regulation is already applying many of the Convention's principles on a mandatory basis, no significant changes to existing arrangements will be necessary.

Certain amendments will, however, be needed to take account of the Convention's stricter provisions, for example as regards the timing and frequency of export notifications, and the level of information required. Also, the proposed new Council Regulation will need to contain appropriate provisions relating to technical assistance for capacity building, in line with the obligations imposed by the Convention on those Parties with more advanced programmes for regulating and managing chemicals.

The proposed Regulation would provide for the implementation on a mandatory basis of the interim arrangements under the Convention pending its entry into force. It would also provide the possibility to continue to apply some of these arrangements to non-Parties to the Convention after it comes into force.

At the same time, the proposed new Council Regulation will go beyond the provisions of the Convention. In the Commission's view it is necessary to preserve or reinforce certain provisions of the existing Regulation so as to ensure that levels of protection for the environment and public health in importing countries provided under the current rules are not weakened. Article 15.4 of the Convention gives the right to Parties to take more stringent action than that called for under its provisions provided that such action is consistent with the Convention and is in accordance with international law.

The more stringent approach the Commission proposes applies particularly as regards the field of scope of the rules, which will impact especially in relation to European Community export notifications forwarded bilaterally to third countries. There should thus, for example, continue to be a specific category for dangerous chemicals banned or severely restricted for consumer use. This would extend not only to chemicals but also to preparations containing those chemicals if the presence of those chemicals would result in the preparation having to be labelled under Community legislation. In addition there should be export notifications for articles containing certain chemicals in unreacted form that could present a risk of release in use or disposal.

Moreover to avoid importing countries receiving chemicals that are banned or severely restricted within the sense of the Convention they do not wish to have because they have failed to give a reaction to an export notification or an import response under the international PIC procedure, it seems appropriate to require the exporter to obtain the explicit consent of the importing country before exporting those chemicals. In addition, for certain chemicals and articles which give rise to particular concern, which are banned for use within the Community and which are not necessarily all subject to the export notification and explicit consent procedures under the regulation, it is desirable to ban their export altogether.

Furthermore, it is appropriate that the current rules on export notifications for banned or severely restricted chemicals, as well as on packaging and labelling for all exported dangerous chemicals, adapted as necessary to take account of the Convention's provisions and other necessary changes, should continue to apply to exports to all importing countries, irrespective of whether or not these countries become Parties to the Convention. Similarly, it seems right and appropriate that the Community should extend the Convention's provisions on information exchange and technical assistance to all countries, in particular with a view to enabling them to implement the Convention.

Such an approach will reaffirm the Community's commitment towards ensuring proper control in the trade and use of dangerous chemicals at the global level, based on the principle that it should help to protect human health and the environment beyond its borders as well as within.

Legal basis

Although the Convention is intended to serve a number of aims, its main objective and its core provisions relate to rules and procedures for the international trade of certain hazardous chemicals. Accordingly, the proposed Regulation is based on Article 133 (relating to the Common Commercial Policy) of the Treaty. This proposed Regulation is of relevance for the European Economic Area (EEA).

6. Content of the Regulation

As noted above, the proposed Regulation would revoke and replace Council Regulation (EEC) No 2455/92 in its entirety. However it should be borne in mind that many of the provisions are based on the latter's provisions or adaptations thereof.

The following summarises the main content of the proposed Regulation.

Article 1

This Article outlines the objectives of the Regulation, which are in line with the overall objectives of the Convention.

Article 2

Article 2 outlines the scope of the Regulation, identifying the kinds of chemicals, in the form of substances by themselves or in a preparation, that are included and those excluded. The Regulation covers certain hazardous chemicals that are subject to the PIC procedure under the Convention, certain hazardous chemicals that are banned or severely restricted within the Community, and all chemicals when exported so far as their packaging and labelling is concerned. The exemptions are broadly in line with those provided for in the Convention, with certain clarifications, taking into account relevant Community legislation.

The main point of divergence from the Convention relates to human or veterinary medicinal products, where it does not seem appropriate to exempt all medicines given that there are some (such as disinfectants, parasiticides and other biocides) which might fall within the definition of pesticides as laid down in the FAO Code of Conduct (which can largely be regarded as the "default" definition for the purposes of implementing the Convention, which does not contain any definition of pesticides). The Convention's exemption for chemicals imported by an individual for personal use has also not been retained since it is difficult to see how this could be effectively policed.

Article 3

Article 3 sets out the definitions used for the purpose of the Regulation. These include those taken from the definitions used in the Convention, adapted as necessary. The most important changes are as follows.

The Convention has only two categories of chemicals: pesticides (including severely hazardous pesticide formulations) and industrial chemicals. However in the interests of openness and transparency it seems appropriate to provide further differentiation in the Regulation by introducing sub-categories within these two categories. Accordingly, it is proposed that the pesticides category should be divided into two sub-categories: plant protection products, and others, including biocides. This distinction reflects the fact that there is different Community legislation applicable to different types of pesticides. It is also proposed that industrial chemicals should be split into two sub-categories: those for use by professionals and those for use by the general public. This would be in line with the approach followed in Council Regulation (EEC) No 2455/92 and the Community's negotiating position during the negotiation of the Convention.

The use of these sub-categorisations implies that more chemicals will be subject to the proposed Regulation than would be the case if the Convention's categories were followed. This is because according to its provisions a chemical that was, for example, severely restricted within the Community as a plant protection product would not become subject to its rules if the chemical also had an important use as a biocide since in order to qualify as a "severely restricted" chemical under the Convention, "virtually all use" within the pesticide category as a whole would have to be prohibited. The Commission considers that such a limitation would undermine the underlying objective of protecting human health and the environment in importing countries. It is vitally important that there should be a maximum flow of information to third countries about chemicals that have given sufficient cause for concern for regulatory action to have been taken to impose bans or restrictions within the Community.

In practice the above line of approach means that all chemicals that are regarded as banned or severely restricted within the Community in any of the above use sub-categories will be subject to export notification when exported outside the Community. However the Commission does not consider that it would be appropriate to extend this line to PIC notifications, i.e. the notification of Community regulatory actions to the PIC secretariat, with a view to the possible inclusion of the chemicals in the international PIC procedure, since this would cause confusion and render the agreed international arrangements unworkable. Only substances which qualify as banned or severely restricted within the terms of the Convention will be so notified.

For similar reasons, the export notification procedure should also be extended to chemicals that are subject to the international procedure since by definition these are hazardous chemicals that importing countries should be alerted to unless they have already consented to imports.

In addition, the proposed Regulation goes further than the Convention by the addition of the concept of "articles" including certain chemicals. Importing countries should be made aware of the health and/or environmental problems related to finished goods containing chemicals that have been banned or severely restricted for such purposes, particularly when these chemicals could be released during use or disposal. Widening of the scope of all the provisions of the Regulation to every such article however would be administratively very burdensome and could be confusing to exporters and other countries. It is therefore proposed that only the export notification procedure be extended to such articles when they contain unreacted forms of chemicals that have been banned or severely restricted within the Community and are subject to the international PIC procedure or qualify for a PIC notification by the Community. Where particular chemicals contained in articles are especially problematic, it is proposed that these should not be exported.

Article 4

The wording of this Article relating to designated authorities is in line with the Convention. It broadly mirrors that in the existing Regulation and reflects current practice within the Community.

Article 5

This Article relates to the Community's participation in the Convention. Like Article 4, the wording reflects that in the current Regulation and existing practice. Some clarifications have been introduced over the role of the Commission in the context of the Convention (for which it will act as the common designated authority for the Community).

Article 6

This Article defines the chemicals that are subject to export notification, qualify for PIC notification, and are subject to the international PIC procedure. As noted above, the export notification procedure will apply to all chemicals that are banned or severely restricted by the Community in one or more categories or sub-categories of use and to all chemicals that are subject to the international PIC procedure. These chemicals are listed in Part 1 of Annex I to the Regulation. The PIC notification procedure on the other hand will be limited to those chemicals that are banned or severely restricted by the Community within one or more use categories. These chemicals will also be listed in Part 2 of Annex I. Finally, the chemicals subject to the international PIC procedure (previously listed in Annex II of the Regulation (EEC) No 2455/92) are listed in Part 3 of Annex I. For transparency reasons, the Annex contains more details than in the past and will be published on the internet.

The most important sources of bans or severe restrictions on chemicals within the EU are Council Directive 76/769/EEC restricting the marketing and use of certain dangerous substances and preparations and Council Directive 79/117/EEC prohibiting the placing on the market and use of plant protection products containing certain active substances. Both have been amended frequently to introduce new controls on dangerous chemicals. In addition, other relevant legislation, such as Council Directive 91/414/EEC concerning the placing of plant protection products on the market and Directive 98/8/EC of the European Parliament and of the Council concerning the placing of biocidal products on the market, provide further points of reference.

Article 7

Article 7 establishes the export notification procedure to be followed, including the deadlines to be respected. It is based on the corresponding provisions of Regulation (EEC) No 2455/92, adapted in the light of the Convention's provisions. The procedure applies to all exports of dangerous chemicals that are regarded as banned or severely restricted within the Community in any use category or sub-category, and to all chemicals subject to the international PIC procedure, irrespective of whether or not the importing country is a Party to the Convention. Such chemicals will be listed in Part 1 of Annex I to the proposed Regulation. The notification must provide the information laid down in Annex III of the proposed Regulation. The Commission will have the central role in sending notifications to importing countries.

The most significant change compared with Regulation (EEC) No 2455/92 is the alteration from a system requiring one export notification before the first export of a chemical to a country into a system of one export notification before the first export of a chemical each year by each exporter. This goes beyond the requirements of the Convention, which impose an obligation of annual export notifications only at the level of each Party. However the Commission will forward only the export notification of the first exporter of the chemical each calendar year to the importing country. Additional information on other exporters will be provided to the importing country only upon request. Moreover there will no longer be a need for export reference numbers to be assigned and used for each subsequent export as under Regulation (EEC) No 2455/92. The new system, which is already anticipated under the voluntary commitments of FECC and CEFIC (referred to above), will therefore result in a more simplified and streamlined procedure.

There will be a centralised register of notifications on the Commission's EDEXIM database and this information will be made available on the internet (information on individual exporters will not be published).

The Designated National Authority of the Member State concerned may waive the export notification requirement if the export relates to an emergency situation where delay could endanger public health or the environment in the importing country.

The Article also defines the circumstances in which the obligations to submit export notifications would cease, for example when the chemical is listed in Annex III to the Convention and is thus subject to the international PIC procedure and the importing Party to the Convention has given an import response (unless that import response specifies otherwise).

Lastly, this Article provides for the possibility for Member States to charge an administrative fee to offset their costs in administering the export notification procedure. This is a new provision not found in Regulation (EEC) No 2455/92 or the Convention. However it is fully consistent with the approach taken in other Community legislation in the chemicals field.

Article 8

This Article outlines the procedure for handling export notifications from third countries and is broadly in line with the corresponding provisions of Regulation (EEC) No 2455/92. The Commission will have the central role, publishing the information on its database and forwarding the material on request to Member States.

Article 9

Article 9 introduces new provisions requiring regular reports on the quantities of chemicals involved. In particular, exporters will be obliged to provide Member States with annual reports on the amounts exported to each country of destination and details of the importers receiving the shipments. This requirement goes further than the Convention, but is already covered in the industry's voluntary commitments. In addition Community importers will also be obliged to provide information about chemicals imported into the Community.

Member States will, on the basis of the information provided by the exporters, compile an overall report at national level in accordance with Annex IV of the proposed Regulation that will be forwarded to the Commission. It will in turn summarise the information at Community level and publish a non- confidential version.

The Commission believes that these reporting arrangements will increase transparency and improve monitoring and control. They will also help to evaluate the impact and effectiveness of the system. Furthermore, the reports will facilitate the provision of any information needed by importing countries to allow them to assess what action they may need to take, while at the same time safeguarding commercially confidential information.

Article 10

This Article sets out the provisions relating to participation in the international notification of exports of banned or severely restricted chemicals under the Convention, the so-called PIC notification procedure. These are essentially based on the corresponding provisions of Regulation (EEC) No 2455/92, having regard also to the rules of the Convention.

Where a chemical qualifies for PIC notification because it has been banned or severely restricted in the Community within one or more of the use categories laid down in the Convention, the Commission shall notify the Convention's Secretariat of the relevant final Community regulatory action, providing the information laid down in Annex II to the proposed Regulation. These chemicals will be listed in Part 2 of Annex I of the proposed Regulation, in addition to being listed in the Part 1.

As regards the information flow relating to regulatory actions taken by other Parties to the Convention, provision is made for the information to be evaluated, and any necessary measures taken, under the appropriate Community instruments.

Article 11

This Article provides that when a chemical is banned or severely restricted within the Community and becomes subject to the export notification procedure under Article 7, but fails to qualify as a candidate for PIC notification under Article 10, the Commission will inform the PIC Secretariat of the relevant regulatory action in accordance with the information exchange provisions laid down in Article 14(1)(c) of the Convention.

Article 12

Article 12 deals with obligations in relation to imports of chemicals. In particular it lays down the procedure for handling decision guidance documents from the PIC secretariat for chemicals subject to the international PIC procedure (listed in Annex III to the Convention); and taking Community import decisions for the chemicals concerned. It is based on the corresponding provisions of Regulation (EEC) No 2455/92, adapted in the light of the Convention's provisions and the need for certain clarifications. Here again, the Commission will have the central role in collaboration with the Member States. In order to meet the deadlines for decisions laid down in the Convention, it is proposed that the advisory committee procedure laid down in the second paragraph of Article 24 be used.

Provision is made that, where appropriate, the information contained in the decision guidance document will be evaluated so that any necessary measures on the chemical concerned can be taken under appropriate Community instruments.

Article 13

This Article sets out certain obligations in relation to exports other than export notification. There are two main elements.

The first relates mainly to procedures for chemicals subject to the international PIC procedure (listed in Part 3 of Annex I to the Regulation) and ensuring that the import decisions of importing parties are respected. These are broadly based on the procedures in the Convention, but with some stricter requirements. The article provides for transparency and distribution of information by the Commission and Member States to help ensure compliance.

The so-called "status quo" provisions of the Convention have not however been retained. This means that if any Party or other country fails to give its explicit consent for the import of any chemical subject to the PIC procedure the chemical should not be exported. Likewise, any chemical that is banned or severely restricted within the Community and qualifies for PIC notification but is not part of the international PIC procedure shall not be exported without the explicit consent of the importing country. Such measures should help to ensure that exports do not proceed simply because of the importing country's failure to give an import response or otherwise fail to react for whatever reason to an export notification.

The second element comprises obligations of a more general nature, which also go beyond the existing rules and the Convention. Customs codes will be assigned to each banned or severely restricted chemical to facilitate control in factories and at EU borders. In addition, in line with the objectives of the proposed Regulation, certain minimum standards are imposed as regards the useful life of exported chemicals, the purity specifications of pesticides and their packaging, storage and stability in order to minimise risks under conditions of use in developing countries.

Article 14

This Article extends the export notification procedure laid down in Article 7 to chemicals subject to the international procedure or banned or severely restricted within the Community and qualifying for PIC notification when contained in unreacted form in articles. It also provides for certain chemicals and articles giving rise to particular concern, such as mercury-containing soaps, the use of which is prohibited in the Community, not to be exported. These chemicals and articles, to be determined by the Council, will be listed in Annex V to the Regulation

Article 15

This Article deals with the question of information on transit movements for chemicals subject to the international PIC procedure. It elaborates on the relevant provisions of the Convention in this regard. The details of the importing Parties requiring information and the type of information to be provided will be set out, as they become available, in Annex VI to the proposed Regulation

Article 16

Article 16 lays down the rules applicable to information to accompany exported chemicals. The provisions are basically the same as those in Regulation (EEC) No 2455/92, partly amended in the light of the Convention, but with certain adaptations.

The key provision is that without prejudice to the requirements of the importing country, and taking into account relevant international standards, all dangerous chemicals for export should be subject to packaging and labelling in accordance with relevant Community legislation, whether or not these chemicals are banned or severely restricted within the Community or are subject to the international PIC procedure. This is in line with Regulation (EEC) No 2455/92, but goes beyond the strict requirements of the Convention. Likewise, it is proposed that all dangerous chemicals shall also be accompanied by a safety data sheet in accordance with Community legislation, even though the Convention limits obligations in this regard to PIC chemicals only. In addition, to improve the information given to users, there is a new requirement that the label should show the expiry date of the chemicals, when relevant (for example in the case of pesticides). The article also provides that as far as possible the information on the label and safety data sheet should be in the principal language(s) of the importing country.

Article 17

This Article is a new provision underlining the obligations of the Customs Services of the Member States under the proposed Regulation. Clearly they will have an important role in ensuring compliance with the rules.

Article 18

This Article is a standard provision for penalties in the event of infringements.

Article 19

Article 19 reflects the provisions of the Convention relating to information exchange, but extends these arrangements to all countries. In line with the Convention, it also defines what kinds of information shall not be regarded as confidential for the purposes of exchange.

The reference to participation by the Commission and the Member States in the Information Network on capacity building set up by the Intergovernmental Forum on Chemical Safety (IFCS) is however new. This network is not yet in place. However the Commission fully supports this initiative and believes that it can make an important contribution towards improving the management of chemicals in developing countries and countries in transition, and thus underpin one of the key objectives of the Convention.

Article 20

This Article is closely related to Article 19. It is largely based on the Convention and sets out the general obligations of the Commission and the Member States in providing technical assistance to developing countries and countries with economies in transition, as well as identifying specific areas of activity that may help such countries implement the Convention. In addition, the important role that NGOs can play in this process is recognised.

Article 21

Article 21 deals with monitoring and reporting within the Community on the operation of the proposed Regulation and is more or less the same as the corresponding provision in Regulation (EEC) No 2455/92.

Both the Member States and the Commission will monitor developments. On the basis of the information provided by Member States and its own monitoring, the Commission will regularly report to the European Parliament and the Council on the overall functioning of the Regulation.

Article 22

Article 22 sets out the procedures to be followed for updating all annexes except Annex V and should be read in conjunction with Article 24.

Chemicals may be included in Part 1 of Annex I if a ban or severe restriction affects any one of the sub-categories of use laid down in the proposed Regulation. Chemicals may be included in Part 2 of Annex I if a ban or severe restriction affects one or more of the use categories.

Decisions on inclusions in these two parts of Annex I will be decided without undue delay after the regulatory action has been taken, using the regulatory committee procedure laid down in the third paragraph of Article 24.

To avoid an unduly cumbersome procedure, and in the interests of speed and operational efficiency, all other changes to this Annex and Annexes II to IV and VI (many of which may derive from changes in the operation of the Convention itself) will be decided using the advisory committee procedure.

Article 23

This Article is a new provision that foresees that technical guidance documents will be drawn up to help in implementing the proposed Regulation. Similar documents have been provided for in the context of Regulation (EEC) No 2455/92 and other recent legislation in the chemicals field such as Directive 98/8/EC concerning the placing of biocidal products on the market.

Article 24

As noted above, this Article outlines the committee procedures to be followed. No new committee structure will be needed. The Commission will be assisted using the committee established by Article 29 of Council Directive 67/548/EEC.

Articles 25 and 26

These two Articles are standard articles relating respectively to repeal of Regulation (EEC) No 2455/92 and entry into force of the proposed new Regulation.

Annexes

Annex I to the Regulation comprises three lists. The first list contains the chemicals banned or severely restricted in the Community in one or more of the subcategories of chemicals covered by the Regulation and the chemicals which are subject to the international PIC procedure and which are subject to the export notification procedure. The second list comprise the chemicals banned or severely restricted in the Community within one or more of the use categories and therefore qualify for PIC notification to the Convention's Secretariat. The third list contains the list of chemicals subject to the international PIC procedure, as listed in Annex III to the Convention as subsequently modified.

The chemicals listed in the first list are subject to the rules on export notifications laid down in Article 7 of the proposed Regulation. The chemicals listed in the second list qualify for the PIC notification procedure pursuant to Article 10. They are also subject to the obligations in relation to export of chemicals in Article 13 and in relation to the export of articles containing chemicals in unreacted form under Article 14(1) insofar as explicit consent of the importing country is concerned. The chemicals contained in the third list are those subject to the international PIC procedure. They are subject to the obligations in relation to compliance with the import decisions of importing countries laid down in Article 13, including in particular the requirement for explicit consent. Where they are also banned or severely restricted within the Community within one of the use categories laid down in the Convention they are also subject to the obligations of Article 14(1) as regards the need for explicit consent for articles containing the chemicals in unreacted form.

Annex II sets out the information that must be submitted by the Commission when notifying the PIC Secretariat of final Community regulatory action pursuant to Article 10 of the proposed Regulation. It corresponds to Annex I of the Convention.

Annex III lists the information that must be submitted by an exporter in submitting an export notification pursuant to Article 7 of the proposed Regulation. This list is based on Annex III to Council Regulation (EEC) No 2455/92, adapted to take account of the requirements of Annex V to the Convention.

Annex IV sets out the information to be provided annually by the Member States to the Commission pursuant to Article 9 of the Regulation about quantities and destinations of exports of chemicals listed in Annex I.

Annex V lists the chemicals and articles, which are prohibited in the Community that shall not be exported in accordance with Article 14(2) of the Regulation.

Annex VI lists parties requiring information on transit movement of chemicals subject to the PIC procedure as details become available (Article 15 of the proposed Regulation refers).

An annex corresponding to the current Annex II in Regulation (EEC) No 2455/92 (listing the import decisions under the international PIC procedure as reported by the Secretariat) is no longer necessary since the relevant provisions of the draft Regulation (see Article 13) refer directly to the information in this regard as circulated under the Convention, for example through PIC circulars, which are also available on the website of the Secretariat.

7. External consultations

Over the last two to three years numerous parties have been consulted, including within the framework of the regular meetings of Designated National Authorities under Regulation (EEC) No 2455/92. These have included stakeholders such as industry and NGOs as well as Member States, all of whom have had an opportunity to give their opinions and to make comments. The proposed Regulation takes account of the views expressed.

8. Evaluation

It is difficult to make a precise assessment of the impact of the proposed Regulation. The proposed Regulation goes beyond the requirements of the Convention in certain respects. However in several cases these additional requirements are not new, but have been carried over from the existing Community rules or are already being anticipated by industry through its unilateral commitments.

As currently proposed, Part 1 of Annex I to the proposed Regulation comprises around 70 chemicals or groups of chemicals (totalling some 300 individual chemicals) that are regarded as banned or severely restricted in the Community or are subject to the international PIC procedure, and thus subject to the export notification procedure. Of the chemicals listed in Part 1, there are about 20 chemicals or groups of chemicals that are banned or severely restricted in the Community within one or more of the use categories prescribed in the Convention, thus qualifying for PIC notification of the related regulatory actions (listed also in Part 2), and 31 chemicals or groups of chemicals that are currently subject to the international PIC procedure (listed in Part 3). There is some overlap between the first and third lists. All 31 PIC chemicals appear in both lists. Moreover of the PIC chemicals or groups of chemicals, 19 are banned or severely restricted within the Community. Export notifications generally will not be needed for any PIC chemicals if the importing Party has provided an import response (unless that import response specifies otherwise).

Over time the number of chemicals subject to the rules will inevitably grow, perhaps significantly. However, these will still represent only a tiny fraction of the total number of chemicals in production. Moreover, it should be noted that several of the chemicals banned or severely restricted within the Community in a Convention use category are no longer produced there, so that for such chemicals the question of export notifications will not arise. As at March 2001, since Regulation (EEC) No 2455/92 (which lists 39 groups of chemicals as banned or severely restricted within the Community) came into force the total number of export notifications had been 344 and these have related to only 14 of the 39 chemical groups, with the vast majority of the notifications relating to mercury compounds.

The proposal to require annual export notifications by each exporter for each exported chemical will obviously increase the numbers in future notifications, but it is not possible to quantify this at this stage. Also, the extended scope of the Regulation in terms of the categories of chemicals covered and the inclusion of certain articles could add significantly to the increase in the number of export notifications. On the other hand, the procedure has been simplified, as exporters do not have to search for and use export reference numbers.

So far as the impact on Community exporters is concerned, overall there is not expected to be any significant increase in the financial and administrative burdens imposed compared with the existing situation. In particular, SMEs are unlikely to be affected since they are generally not involved in the production of the chemicals subject to the proposed Regulation. The Regulation will increase the number of chemicals subject to the international PIC procedure at a more moderate rate since only relevant Community regulatory actions banning or severely restricting chemicals within one or more of the use categories laid down in the Convention would be notified to the PIC Secretariat. This does not necessarily mean that these notifications will lead to the chemical's inclusion in the international PIC procedure. The inclusion process is by no means automatic given the safeguards laid down in the Convention. Furthermore even if inclusion follows and this leads to negative import decisions by other countries, under the Convention such bans on the chemicals will have to apply to imports from whatever source as well as to domestic production to prevent discriminatory treatment. In addition such action may well lead to a demand for alternative chemicals, which Community exporters would be well placed to meet. Overall, therefore, Community exporters should not be placed at a serious competitive disadvantage vis-à-vis their competitors.

The new requirement to obtain the explicit consent of importing countries for certain chemicals is unlikely to have any major adverse impact on exporters generally. The number of chemicals concerned corresponds to those qualifying for PIC notification or included in the international PIC procedure and is lower than that for export notifications. This additional burden seems justified relative to the improved protection of human health and the environment, particularly in those countries that fail to provide PIC import responses and hence are especially vulnerable to unwanted imports. Furthermore, the overall impact in relation to articles should be very limited given that the marketing and use of the chemicals concerned is already banned or severely restricted within the Community so that not many articles should be produced for export. Likewise, the proposed ban on the export of a limited number of chemicals and articles giving rise to particular concern should not have any significant adverse effect on Community exporters overall and will send an important signal to other countries, especially developing countries.

There will be an impact in terms of increased administrative burdens on Member States and on the Commission in terms of the number of export notifications to be handled. It is difficult to quantify this at this stage and this will have to be assessed after the system has been in operation.

Against any costs have to be weighed the benefits. It is clearly essential that importing countries, and particularly developing countries, should be made aware of the hazards of dangerous chemicals and how to prevent harm to people and the environment. The proposed Regulation will not only fulfil the Community's obligations under the Convention. It will also, in going beyond the provisions of the Convention, provide a further important contribution towards improving access to information on dangerous chemicals and raising global protection of the population and the environment from dangerous chemicals. This is a very important objective for the Community.

2002/0026 (ACC)

Proposal for a COUNCIL REGULATION concerning the export and import of dangerous chemicals

(Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community, and in particular Article 133 thereof,

Having regard to the proposal from the Commission [3],

[3] OJ C , , p. .

Having regard to the opinion of the European Parliament [4],

[4] OJ C , , p. .

Having regard to the opinion of the Economic and Social Committee [5],

[5] OJ C , , p. .

Whereas,

(1) Council Regulation (EEC) No 2455/92 of 23 July 1992 concerning the export and import of certain dangerous chemicals [6] 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).

[6] OJ L 251, 29.08.1992, p. 13. Regulation as last amended by Commission Regulation (EC) No 2247/98 (OJ L 282, 20.10.1998, p. 12).

(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 one or more 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 provisions. 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) Community notifications to the Secretariat of the Convention of Community 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 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. 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 are not 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 decided 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 all 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 customs services of the Member States have a key role to play and should act in a targeted and co-ordinated way. Member States should provide for appropriate sanctions in the event of infringements.

(17) Information exchange, shared responsibility and co-operative efforts between the Community and its Member States and third countries should be promoted with a view to ensuring a 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) Since the measures necessary for the implementation of this Regulation are measures of general scope within the meaning of Article 2 of Council Decision 1999/468/EC of 28 June 1999 laying down the procedures for the exercise of implementing powers conferred on the Commission, [7] they should be adopted by use of the advisory procedure provided for in Article 3 or the regulatory procedure provided for in Article 5 of that Decision, as appropriate.

[7] OJ L 184, 17.7.1999, p. 23.

(20) In the light of the above, Regulation (EEC) No 2455/92 should be repealed and replaced,

HAS 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 co-operative efforts in the international trade 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 [8], and Directive 1999/45/EC of the European Parliament and the Council [9] regarding the classification, packaging and labelling of chemicals dangerous to man or 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.

[8] OJ L 196, 16.8.1967, p. 1.

[9] OJ L 200, 30.7.1999, p. 1.

Article 2

Scope

1. This Regulation applies to:

(a) certain hazardous chemicals that are subject to the prior informed consent procedure under the Rotterdam Convention;

(b) certain hazardous chemicals that are banned or severely restricted within the Community; and

(c) all chemicals when exported in so far 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 [10];

[10] OJ L 357, 20.12.1990, p. 1.

(b) radioactive materials and substances covered by Council Directive 96/29/Euratom [11];

[11] OJ L 159, 29.6.1996, p. 1.

(c) wastes covered by Council Directives 75/442/EEC [12] and 91/689/EEC [13];

[12] OJ L 194, 25.7.1975, p. 39.

[13] OJ L 377, 31.12.1991, p. 20.

(d) chemical weapons covered by Council Regulation (EC) No 1334/2000 [14];

[14] OJ L 159, 30.6.2000, p. 1.

(e) food and food additives covered by Council Directive 89/397/EEC [15];

[15] OJ L 186, 30.6.1989, p. 23.

(f) feedingstuffs covered by Council Directive 96/25/EC [16];

[16] OJ L 125, 23.5.1996, p. 35.

(g) genetically modified organisms as covered by Directive 2001/18/EC of the European Parliament and of the Council [17];

[17] OJ L 106, 17.4.2001, p. 1.

(h) proprietary medicinal products and veterinary medicinal products covered by Directive 2001/83/EC of the European Parliament and of the Council [18] and Directive 2001/82/EC of the European Parliament and of the Council [19], except disinfectants, insecticides and parasiticides;

[18] OJ L 311, 28.11.2001, p. 67.

[19] OJ L 311, 28.11.2001, p. 1.

(i) chemicals in quantities not likely to affect health or the environment, 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 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 as defined in Directive 1999/45/EC if the preparation 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 which has been banned or severely restricted by Community legislation for use in that product;

(4) 'pesticides' means pesticides in either of the following two sub-categories:

(a) pesticides used as plant protection products as covered by Council Directive 91/414/EEC [20];

[20] OJ L 230, 19.8.1991, p. 1.

(b) other pesticides, and in particular biocidal products under Directive 98/8/EC of the European Parliament and the Council [21];

[21] OJ L 123, 24.4.1998, p. 1.

(5) 'industrial chemicals' means chemicals in either of the following two sub-categories:

(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 sub-categories, 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 within one or more categories. These chemicals 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 sub-categories 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 sub-categories 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) 'final regulatory action' means a legislative act, the purpose of which is to ban or severely restrict a chemical;

(12) 'convention' means the Rotterdam Convention of 10 September 1998 on the Prior Informed Consent Procedure for Certain Hazardous Chemicals and Pesticides in International Trade;

(13) 'PIC procedure' means the Prior Informed Consent Procedure established by the Convention;

(14) '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;

(15) '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 are placed under a customs procedure other than transit procedure;

(16) '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;

(17) '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;

(18) '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;

(19) '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;

(20) 'Party' means:

(a) a party to the Convention;

(b) any country which has not ratified the Convention but which participates in the PIC procedure;

(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;

(21) 'other country' means any country that is not a Party as defined in point (20);

(22) '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;

(23) '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;

(24) 'the Secretariat' means the Secretariat of the Convention or, before its entry into force, the interim Secretariat established by the resolution on interim arrangements;

(25) '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 Commission shall act on behalf of all the Designated National Authorities as a unique and common designated authority in the performance of the functions required by the Convention. It shall work in close co-operation with the Designated National Authorities of the Member States.

In particular, the Commission shall co-ordinate the Community input on all 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 different bodies implementing the Convention. In particular, they shall seek to ensure that the Commission receives a seat in the subsidiary bodies established by 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 categories, 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 on the identity of the substance, on the use category and/or sub-category 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 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 and, where appropriate, additional information, in particular on any requirements for export notification.

3. The lists shall be made available to the public via the internet.

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 of 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 8 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 at least 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 according to 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 importation 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:

(a) the appropriate authority of the importing party or other country has waived the requirement to be notified before the export of the chemical; and

(b) 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 the provisions of this Article.

Article 8

Export Notifications received from Parties

1. Export notifications received by the Commission from the Designated National Authority of a party 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 legislation shall be made available on internet through the database maintained by the Commission.

The Commission shall acknowledge receipt of the first export notification received for each chemical from each party.

Upon request, the Designated National Authority of the Member State shall receive a copy of any notification received together with all available information.

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, they shall forthwith 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 time period.

Each importer within the Community shall provide the same information for the quantities imported into Community.

2. Upon request from the Commission or the Designated National Authority, the exporter or importer shall provide any additional information related 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/internet.

Article 10

Participation in the notification of banned or severely restricted chemicals

under the Convention1. 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 ninety days after the date on which the final regulatory action has to be applied.

It 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, to what extent 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 has 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 forthwith 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 co-operation 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. Member States shall not submit notifications to the Secretariat regarding final regulatory actions.

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 the Part 1 of Annex I, the Commission shall provide the Secretariat with information about the relevant regulatory actions that lead to the chemical's inclusion, 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 forthwith 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 importation 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. An import decision under paragraph 1 shall relate to the category or categories specified for the chemical in the Decision Guidance Document.

3. 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.

4. 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.

5. Where appropriate, the Commission shall evaluate, in close co-operation 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.

Article13

Obligations in relation to exports of chemicals other than export notification requirements

1. The Commission shall forward forthwith 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 forthwith 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 effected 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 importation 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 importation 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 importation.

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, 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 required for each party to the Convention having expressed such need 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 30 days before the first transit takes place and 8 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, 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 [22] shall accompany chemicals referred to in paragraph 1, when exported. The exporter shall send such a safety data sheet to each importer.

[22] OJ L 76, 22.3.1991, p. 35.

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 Customs Services of the Member States

Each Member State shall designate a limited number of customs offices 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 co-ordinated 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 Customs Services 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 six 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 as mutually agreed.

3. As regards the transmission of information under this Regulation, and without prejudice to Council Directive 90/313/EEC [23] concerning freedom of access to information on the environment, the following shall not be regarded as confidential:

[23] OJ L 158, 23.6.1990, p. 56.

(a) the information 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.

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 on the projects they are supporting or financing to improve the management of chemicals in developing countries and countries with economies in transition.

A compilation of these activities 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, co-operate 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, 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 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 the 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 regular intervals, 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 sub-categories within the categories 'pesticides' and 'industrial chemicals'. If the regulatory action bans or severely restricts a chemical in any one of the sub-categories 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 Communities.

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, the advisory procedure laid down in Article 3 of Decision 1999/468/EC shall apply, in compliance with Article 7 thereof.

3. Where reference is made to this paragraph, the regulatory procedure laid down in Article 5 of Decision 1999/468/EC shall apply, in compliance with Article 7 thereof.

The period provided for in Article 5(6) of Decision 1999/468/EC shall be three months.

Article 25

Repeal

Regulation (EEC) No 2455/92 is hereby repealed.

Article 26

Entry into force

This Regulation shall enter into force on 1 January 2003.

This Regulation shall be binding in its entirety and directly applicable in all Member States.

Done at Brussels,

For the Council

The President

ANNEX 1

PART 1: LIST OF CHEMICALS SUBJECT TO EXPORT NOTIFICATION PROCEDURE

(Article 7 of the 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 paragraphs 1 to 3 of Article 7 of the Regulation shall not apply provided that the conditions laid down in subparagraphs (b) and (c) of paragraph 5 of the same Article have been fulfilled. Such chemicals, which are identified by the symbol

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 POSITION>

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* Sub- Category: p(1) - pesticide in the group of plant protection products, p(2) - other pesticide including biocides. i(1) - industrial chemical for professional use and i(2) - industrial chemical for public use

** Use limitation: sr - severe restriction, b - ban (for the sub-category or sub-categories concerned) according to Community legislation

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 the 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 POSITION>

* Category: p - pesticide s. i - industrial chemical

** Use limitation: sr - severe restriction, b - ban (for the category or categories concerned)

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 the Regulation)

(The categories shown are those referred to in the Convention)

>TABLE POSITION>

ANNEX II

NOTIFICATION OF A BANNED OR SEVERELY RESTRICTED CHEMICAL TO THE SECRETARIAT OF THE CONVENTION

Information requirements for notifications pursuant to article 10.

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 EU

in the importing country;

(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, include 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

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) EC 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) The 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) The name, address, telephone and telex, fax number or E-mail of the designated authority in the importing country.

5. Informatio