EN Official Journal of the European Union C 65/1

COMMUNICATION FROM THE COMMISSION

TECHNICAL GUIDANCE NOTES FOR IMPLEMENTATION OF REGULATION (EC) No 689/2008

Publication made in accordance with Article 23 of Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals

2011/C 65/01

TABLE OF CONTENTS

1. INTRODUCTION

2. THE ROTTERDAM CONVENTION

3. REGULATION (EC) No 689/2008

3.1. Article 1: OBJECTIVES

3.2. Article 2: SCOPE

3.3. Article 3: DEFINITIONS

3.4. Article 4: DESIGNATION OF NATIONAL AUTHORITIES

3.5. Article 5: PARTICIPATION OF THE EUROPEAN UNION IN THE CONVENTION

3.6. Article 6: CHEMICALS SUBJECT TO EXPORT NOTIFICATION, CHEMICALS QUALIFYING FOR PIC NOTIFICATION, AND CHEMICALS SUBJECT TO THE PIC PROCEDURE

3.7. Article 7: EXPORT NOTIFICATIONS FORWARDED TO THIRD COUNTRIES

3.8. Article 8: EXPORT NOTIFICATIONS FROM THIRD COUNTRIES

3.9. Article 9: INFORMATION ON EXPORT AND IMPORT OF CHEMICALS

3.10. Article 10: PARTICIPATION IN THE PIC NOTIFICATION PROCEDURE

3.11. Article 11: INFORMATION TO BE SUBMITTED TO THE PIC SECRETARIAT ON CHEMICALS NOT QUALIFYING FOR PIC NOTIFICATION

3.12. Article 12: OBLIGATIONS IN RELATION TO IMPORTS OF CHEMICALS

3.13. Article 13: OBLIGATIONS IN RELATION TO EXPORTS OF CHEMICALS OTHER THAN EXPORT NOTIFICATION

3.14. Article 14: EXPORTS OF CERTAIN CHEMICALS AND ARTICLES CONTAINING CHEMICALS

3.15. Article 15: INFORMATION ON TRANSIT MOVEMENTS

3.16. Article 16: INFORMATION TO ACCOMPANY EXPORTED CHEMICALS

3.17. Article 17: OBLIGATIONS OF MEMBER STATES AND EXPORTERS FOR CONTROLLING IMPORT AND EXPORT

3.18. Article 18: PENALTIES

3.19. Article 19: INFORMATION EXCHANGE

3.20. Article 20: TECHNICAL ASSISTANCE

3.21. Article 21: MONITORING AND REPORTING

3.22. Article 22: UPDATING ANNEXES

3.23. Article 23: TECHNICAL NOTES FOR GUIDANCE

3.24. Article 24: COMMITTEE

4. THE EUROPEAN DATABASE ON EXPORT AND IMPORT OF DANGEROUS CHEMICALS

5. EXAMPLES

ANNEX 1 — Annex I to Regulation (EC) No 689/2008 of the European Parliament and of the Council

ANNEX 2 — Annex II to Regulation (EC) No 689/2008

ANNEX 3 — Annex V to Regulation (EC) No 689/2008

ANNEX 4 — Flow charts on the main procedures

ANNEX 5 — Overview of exporters’ main tasks in order to comply with Regulation (EC) No 689/2008

ANNEX 6 — List of recommended languages for the labelling of exports to certain countries

ANNEX 7 — List of Designated National Authorities for Regulation (EC) No 689/2008

ANNEX 8 — List of OECD countries to which waiver for explicit consent could be applied

DISCLAIMER

This Guide does not create any new legislative rules. It reflects the Commission’s understanding of Regulation (EC) No 689/2008 and the other legislation referred to. It does not create any new rights or obligations not provided for therein. It should be noted that, in any event, the binding interpretation of Union law is ultimately the role of the Court of Justice of the European Union.

ABBREVIATIONS AND DEFINITIONS USED

CLP Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 CoP Conference of the Parties DNA Designated National Authority EDEXIM European Database Export Import of Dangerous Chemicals EC European Community EEC European Economic Community EU European Union FAO Food and Agriculture Organization of the United Nations GHS Globally Harmonised System of Classification and Labelling Hazard Statement means a phrase assigned to a hazard class and category that describes the nature of the hazards of a hazardous substance or mixture, including, where appropriate, the degree of hazard OECD Organisation for Economic Cooperation and Development PCBs Polychlorinated biphenyls PIC Prior Informed Consent POPs Persistent organic pollutants Precautionary Statement means a phrase that describes recommended measure(s) to minimise or prevent adverse effects resulting from exposure to a hazardous substance or mixture due to its use or disposal R-phrases Phrases describing the risks arising from the dangers involved in using the substance REACH Regulation (EC) No 1907/2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals RIN Reference Identification Number S-phrases Phrases describing safety requirements and emergency response procedures relating to the safe use of the substance TARIC Tarif Intégré de la Communauté — i.e., Integrated Tariff of the European Community TFEU Treaty on the Functioning of the European Union UNEP United Nations Environment Programme

1. INTRODUCTION

The European Union’s chemical industry is one of the world’s largest chemical producers. Its products include a wide range of substances for a multitude of purposes. Some substances are dangerous to human health and/or the environment and must be used under controlled conditions. Certain chemicals manufactured for export and use in other countries are banned or severely restricted within the European Union.

It is important to know how to store, transport, use and dispose of dangerous chemicals safely. It is also vital to know what to do in emergency situations, and how to treat medical and environmental problems quickly and effectively. However, in many countries, particularly developing countries, there is a lack of capacity to manage chemicals safely. Workers are often untrained in the proper use and disposal of dangerous chemicals. Governments and companies in these countries may not have appropriate storage and disposal facilities. They may lack knowledge of the hazards of a chemical and how to prevent harm to people and the environment.

Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 (1) concerning the export and import of dangerous chemicals is the latest in a series of measures over the years that seek to address this issue. It implements within the EU the Rotterdam Convention on the Prior Informed Consent Procedure (PIC) for certain hazardous chemicals and pesticides in international trade, with a view to protecting human health and the environment from potential harm and contributing to the environmentally sound use of such chemicals. The Regulation also implements a requirement of the Stockholm Convention on persistent organic pollutants, as it bans the export of chemicals identified as persistent organic pollutants in the Convention unless there are specific exemptions foreseen in the Stockholm Convention. It replaces Regulation (EC) No 304/2003 (2) of the European Parliament and of the Council. (3)

Regulation (EC) No 689/2008 reaffirms the EU’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. The Regulation is based on Article 133 EC (now Article 207 TFEU) and Article 175 EC (now Article 192 TFEU), in order to reflect the impact of provisions on both trade and environmental issues.

Regulation (EC) No 689/2008 includes a number of technical amendments to the operative provisions of Regulation (EC) No 689/2008 in light of experience with implementation to date. In particular, and in recognition of the difficulties caused by delays in obtaining responses to requests for explicit consent to import, a procedure is foreseen for allowing exports of certain chemicals to proceed on a temporary basis in the case where, despite all reasonable effort, no response is obtained from the importing country. The Regulation outlines the specific conditions required to allow such waivers and establishes relevant timelines. In addition, under certain conditions a waiver from the obligation to obtain explicit consent is provided for when exporting certain chemicals to countries that are members of the Organisation for Economic Cooperation and Development (OECD).

The revised Regulation also enhances and extends the role of the Commission’s database, EDEXIM, by requiring that a system of codes be assigned to export notifications, import decisions, consents and waivers that are maintained in the database. In order to facilitate customs enforcement and reduce administrative burden, exporters are to quote these codes in their export declarations. The Regulation also maintains a number of provisions that go beyond the requirements of the Rotterdam Convention, in order to achieve a higher level of protection to human health and the environment.

This Guide opens in section II with an introduction to the Rotterdam Convention, including its basic principles and mechanisms. This section includes a summary of the areas in which the EU Regulation goes beyond the requirements of the Convention. The Guide continues in section III with an article by article review of Regulation (EC) No 689/2008, in which the key requirements of each provision are clearly explained and the relationship between different provisions highlighted. Section IV then outlines the role of the Commission in the day-to-day implementation of the Regulation and in maintaining the EDEXIM database. Finally, section V provides some examples that demonstrate how the requirements of the Regulation play out practically in a range of cases.

The Annexes provide useful supplementary information. Annexes 1 through 3 reproduce Annexes I, II, and V of Regulation (EC) No 689/2008. Please note that Annex I to the Regulation is subject to regular updates and the most up-to-date version will be kept available at the Commission’s website at: http://edexim.jrc.ec.europa.eu. Annex 4 provides flow charts of the main procedures linked to the exports of chemicals that were established to implement the Regulation, while Annex 5 gives an overview of the exporters’ main tasks. Annex 6 lists the recommended languages for the labelling of exports. Annex 7 lists the Designated National Authorities for the EU Member States, and Annex 8 lists the OECD countries for which a waiver for explicit consent could be applied and their respective DNAs.

It has to be noted that Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (4) (the CLP Regulation) sets out the new rules for classification, labelling and packaging of chemicals in the EU and has already replaced certain parts of Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (5). Regulation (EC) No 1272/2008 will replace Directive 67/548/EEC and Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (6) in full by 1 June 2015. The terminology used in Regulation (EC) No 689/2008 is still based on the former Directives, but will be adapted to the CLP Regulation in the near future. For example, the CLP Regulation does not use the term ‘preparation’ but ‘mixture’ instead. Throughout this guide, the term ‘preparation’ should thus be understood as meaning the same as ‘mixture’ in the CLP Regulation.

2. THE ROTTERDAM CONVENTION

The aim of the Rotterdam Convention on the prior informed consent procedure (PIC) for certain hazardous chemicals and pesticides in international trade is to promote shared responsibility and co-operative efforts among the Parties in the international trade of dangerous chemicals in order to protect human health and the environment from potential harm and to contribute to their environmentally sound use. It was developed on the basis of experience gained in implementing 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 the International Code of Conduct on the Distribution and Use of Pesticides, as amended in 1990, of the Food and Agriculture Organisation (FAO). These instruments provided for a voluntary PIC procedure.

The Convention was adopted and opened for signature at a Conference in Rotterdam in 1998 and entered into force on 24 February 2004. As of 31 October 2010, 139 Parties had ratified. A Conference of the Parties (CoP) takes place every second year. In addition to adopting decisions on both the operative provisions of the Convention and procedural issues related to implementation, the Parties have decided that the Convention Secretariat should be jointly provided by the United Nations Environment Programme in Geneva and the Food and Agriculture Organisation in Rome.

Prior to adoption of the Convention, the European Union participated in a voluntary procedure, which had been made legally binding in the EU through Regulation (EEC) No 2455/92. Following ratification of the Rotterdam Convention by the European Union on 20 December 2002 (see Council Decision 2003/106/EC (7), Regulation (EEC) No 2455/92 was replaced by Regulation (EC) No 304/2003, which fully implemented the provisions of the Convention and included a number of provisions that went beyond the Convention’s requirements. In particular, the EU decided not to limit the scope of the Regulation to chemicals that are subject to the Convention, but to also cover chemicals banned or severely restricted at EU level. As EU legislation developed, four amendments to Annex I were necessary to cover additional chemicals. Regulation (EC) No 689/2008 has now replaced Regulation (EC) No 304/2003 and provisions going beyond the Convention were kept.

The Convention covers two categories of chemicals, namely pesticides and industrial chemicals. The basic principle 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 prior informed consent (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 40 chemicals are subject to the PIC procedure. The Convention establishes a mechanism for including further substances, provided that certain criteria are met.

Parties must notify the Secretariat of all final regulatory actions banning or severely restricting a chemical falling within the scope of the Convention by submitting so-called PIC notifications. PIC notifications are the trigger for inclusion of a chemical in the process. After notifications from at least two Parties belonging to different geographic regions (defined by the 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 of the Convention are met, the CRC drafts a decision guidance document (DGD) and recommends to the CoP that the chemical be listed in Annex III and included in the PIC procedure. The CoP then decides by consensus whether or not the chemical will be so included. The DGD 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 by making available the so-called ‘PIC circulars’ on the PIC website at http://www.pic.int/. The import responses are also published in a database on this website. Exporting Parties are obliged to ensure that their exporters comply with any import decisions. The objective of this obligation is to protect importing countries that do not have the infrastructure to protect themselves sufficiently from unwanted imports.

The other key pillar of the Convention relates to the exchange of information among Parties about potentially hazardous chemicals that may be exported. 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 noted above, there are a number of aspects in which the Regulation goes beyond the requirements of the Rotterdam Convention in order to achieve a higher level of protection of human health and the environment. The requirements for export notification and for explicit consent are extended to all countries, rather than applying only to those countries that are Party to the Convention. The scope of the Regulation is extended to include all chemicals that are banned or severely restricted at EU level. In order to capture more chemicals, the two use categories under the Convention have been divided into two subcategories: pesticides are divided into agricultural and non-agricultural pesticides, and industrial chemicals into chemicals for professional use and chemicals for consumer use. Therefore, under the EU Regulation, the ban or severe restriction of a chemical at subcategory level (even if not banned or severely restricted at Convention use category level) can trigger export notification. Thus some chemicals which do not qualify for PIC notification under Article 5 of the Convention and therefore do not require an export notification under Article 12 of the Convention are nevertheless subject to export notification under the Regulation.

Furthermore, EU exporters are obliged to make export notifications irrespective of the intended use and whether or not that use is banned or severely restricted within the EU. The same rule also applies for requests for explicit consent. Finally, with regards to the requirement for explicit consent, the scope of chemicals included is extended beyond the list of chemicals subject to PIC Procedure under the Convention to include also all chemicals qualifying for PIC notification in any of the two Convention categories.

3. REGULATION (EC) No 689/2008

Regulation (EC) No 689/2008 of the European Parliament and of the Council concerning the export and import of dangerous chemicals was adopted on 17 June 2008, and came into force on 1 August 2008. It replaces Regulation (EC) No 304/2003, which was repealed. The main provisions of the Regulation are described below.

3.1. Article 1: OBJECTIVES

The Regulation has several objectives:

— to implement the Rotterdam Convention (in some cases going beyond its provisions), also in relation to countries that are not party to the Convention;

— to impose the same packaging and labelling requirements for exports of all dangerous chemicals as apply within the EU, unless these are in conflict with requirements of the importing country.

It should be noted that the packaging and labelling of the final product must always conform to the requirements of the importing country in which it is marketed if such requirements exist.

3.2. Article 2: SCOPE

The Regulation covers:

— Chemicals subject to the PIC procedure;

— Chemicals that are banned or severely restricted within the EU;

— All chemicals when exported so far as packaging and labelling is concerned (as per the EU requirements – see Article 16).

The Regulation does not apply to chemicals that are drugs, radioactive materials, wastes, chemical weapons, food and food additives, feeding stuffs, genetically modified organisms, pharmaceuticals (except disinfectants, insecticides and parasiticides), as defined in other EU legislation. Nor does it apply to chemicals exported or imported for research or analysis provided that the quantities are not likely to affect human health or the environment and are in any case not more than 10 kg of the substance by itself or 10 kg of the substance when contained in mixtures (preparations) with other substances.

It should be noted that a special administrative procedure has been set up to facilitate exports that are exempted from the provisions of the Regulation. This exemption applies to chemicals exported for research or analysis in quantities of 10 kg or less. This procedure, known as a special RIN request, is described in chapter 3.17. It should be noted that this procedure is also used for chemicals listed in Annex I Part 3 for which the import decision published in the PIC Circular consents to the import and Article 7(6) applies.

3.3. Article 3: DEFINITIONS

Definitions for the key terms used in the Regulation include: chemical; preparation; article; pesticides and industrial chemicals (these are Convention use categories, which in each case the Regulation divides into two sub-categories); chemical subject to export notification, chemical qualifying for PIC notification, chemical subject to PIC procedure, banned chemical and severely restricted chemical.

For example: a ‘chemical’ is a substance by itself or in a preparation, or a preparation, whether manufactured or obtained from nature, but does not include living organisms. A ‘pesticide’ is a chemical that falls into either of the following subcategories: use as a plant protection product; or other pesticidal use such as a biocidal product. An ‘industrial chemical’ is a chemical falling in either of the following sub-categories: chemical for use by professionals; or chemical for use by the public. A ‘banned chemical’ is one which has been prohibited for all uses within one or more use subcategories or categories by final regulatory action within the EU in order to protect human health or the environment. This includes cases where a chemical has been refused approval for first-time use or has been withdrawn by industry either from the 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. A ‘severely restricted chemical’ is defined similarly and is one for which virtually all uses have been prohibited within one or more use subcategories or categories.

The definitions are broadly in line with those used in the Convention, but with some important differences.

The introduction of chemical use subcategories for the purpose of determining the need for export notification of chemicals banned or severely restricted within the EU means that more chemicals will be subject to export notification than would otherwise be the case. These chemicals are listed in Part 1 of Annex I to the Regulation. However, to qualify also for PIC notification (Part 2 of Annex I), a chemical must be banned or severely restricted within the EU within a Convention use category. A ‘chemical’ includes a substance by itself or in a preparation, i.e. a mixture or a solution composed of two or more substances.

The definitions also include the concept of ‘articles’. These are finished products, containing or including a chemical the use of which has been banned or severely restricted by EU legislation in that particular product. Articles containing such chemicals in unreacted form are subject to export notification. Articles listed in Annex V are subject to an export ban.

Pursuant to the definition of ‘export’, the Regulation applies to exports from the customs territory of the European Union. The customs territory also includes zones where special customs rules apply, for example free zones and customs warehouses.

‘Exporter’ is also specifically defined, and includes the person holding the export contract, or in the absence of a contract, the person having the power to determine the export of the chemical from the customs territory of the European Union (irrespective of from which Member State the export is leaving the customs territory). In the case where the exporter is not established in the EU, the contracting Party established in the EU must fulfil the obligations of the exporter.

Lastly, it should be emphasised that, unless specified to the contrary, the Regulation’s obligations extend to exports to all countries, irrespective of whether or not they are Parties to the Convention.

3.4. Article 4: DESIGNATION OF NATIONAL AUTHORITIES

The Member States must designate one or more national authorities (DNA) to carry out the administrative functions under the Regulation and inform the Commission thereof.

3.5. Article 5: PARTICIPATION OF THE EUROPEAN UNION IN THE CONVENTION

The Commission is the common designated authority for the participation of the European Union in the Convention, working in close cooperation with the DNAs of the Member States. This function includes the transmission of EU export notifications, submission of PIC notifications, receiving of export notifications from third countries, submission of EU import decisions for PIC chemicals and exchange of information with the PIC Secretariat. The Commission also coordinates the EU’s input on all technical issues related to the Convention, the Conference of the Parties and its subsidiary bodies such as the Chemicals Review Committee.

3.6. Article 6: CHEMICALS SUBJECT TO EXPORT NOTIFICATION, CHEMICALS QUALIFYING FOR PIC NOTIFICATION, AND CHEMICALS SUBJECT TO THE PIC PROCEDURE

The chemicals falling under the above categories are listed in Annex I to the Regulation. The list as at the time of publication is reproduced as Annex 1 to this guide. An updated list is available on the EDEXIM website at http://edexim.jrc.ec.europa.eu.

The Annex is organised in three separate parts in line with the categorisations.

Part 1 lists the chemicals or chemical groups that are subject to export notification. This comprises all of the chemicals that are banned or severely restricted within the EU, in at least one of the use subcategories (i.e. pesticide used as a plant protection product, other pesticide such as a biocidal product, industrial chemical for use by professionals, or industrial chemical for use by the public). It also includes the chemicals that qualify for PIC notification and the chemicals subject to the PIC procedure (being listed in Annex III to the Convention).

Part 2 lists the chemicals that qualify for PIC notification because they are banned or severely restricted within the European Union in a Convention use category (i.e. pesticide or industrial chemical).

Part 3 lists the chemicals or chemical groups that are subject to the PIC procedure (being listed in Annex III to the Convention).

The different use categories or subcategories are indicated for each entry. For chemicals that are banned or severely restricted within the EU, the most important sources of relevant regulatory actions currently are: Directive 91/414/EEC (8), which will be replaced by Regulation (EC) No 1107/2009 of the European Parliament and of the Council concerning the placing of plant protection products on the market (9) as from 14 June 2011, Directive 98/8/EC concerning the placing of biocidal products on the market (10) and Regulation (EC) No 1907/2006 of the European Parliament and of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (11).

It should be noted that the lists of chemicals in the various parts of Annex I overlap. All the chemicals found in Parts 2 and 3 are also listed in Part 1 (except for 8 PIC chemicals listed in Part 3 but excluded from Part 1 as they are subject to an export ban according to the provisions of the Stockholm Convention). (12) In addition to export notification, the export of chemicals listed in Parts 2 and 3 also require the explicit consent of the importing country (see Article 13 below).

Annex I to Regulation (EC) No 689/2008 has been amended by Commission Regulations (EU) No 15/2010 and (EC) No 196/2010 and will continue to be updated in the light of further regulatory actions under EU legislation as well as developments under the Convention. The most up-to-date version will be available at the Commission’s website at http://edexim.jrc.ec.europa.eu.

3.7. Article 7: EXPORT NOTIFICATIONS FORWARDED TO THIRD COUNTRIES

The export notification obligation applies to all chemicals in Part 1 of Annex I for export to any country — whether or not that country is a Party to the Convention — and irrespective of the intended use of the chemical. A preparation containing an Annex I chemical is also subject to notification, if the concentration of the chemical is such as to trigger labelling obligations under Directive 1999/45/EC. Certain articles containing Annex I chemicals may also require export notification (see Article 14). A separate export notification must be submitted for each substance, preparation or article concerned and a separate RIN will subsequently be issued.

When an exporter in a Member State within the EU intends to export a specific chemical subject to notification from the EU to a third country for the first time and for the first time in each subsequent year, the export notification procedure must be followed.

However, export notification is no longer required when a chemical becomes subject to the PIC procedure and the importing Party to the Convention has given an import response, unless the importing Party continues to require notification. The requirement also ceases when an importing country officially waives the right to receive export notifications. Such information will be available on the EDEXIM website at http://edexim.jrc.ec.europa.eu, in the section ‘Info Importing Country’.

In all other cases, the exporter must submit an export notification to his DNA at least 30 days before the first export is due to take place, and at least 15 days before the first export in each subsequent calendar year. However, it is recommended to submit the notification as early as possible to the DNA so as to allow enough time for processing.

Subsequent exports of the same chemical to the same country within the same calendar year do not need to be notified, unless otherwise required by importing countries. However the export of the same chemical to another third country will be considered as a ‘first export’ and will also be subject to the export notification procedure.

The information to be provided in the export notification is set out in Annex II to the Regulation, which is attached to this guide as Annex 2. The export notification form available on EDEXIM should be used for the export notification. The DNA, which may charge the exporter an administrative fee to cover its costs, will check the notification and if not satisfied, will contact the exporter without undue delay so that any missing information can be provided. Once an export notification has been uploaded onto EDEXIM (directly by the exporter or via the DNA), this notification is registered in EDEXIM and a reference identification number (RIN) is issued. Pending processing of the notification by the DNA and/or the Commission, the draft notification is kept on EDEXIM. After approval by the Commission, the final notification is sent to the DNA of the importing country along with a confirmation of receipt form and, if submitted by the exporter, a copy of the Safety Data Sheet for the substance or preparation. This final notification is stored on EDEXIM and available to the exporter and the DNAs. The RIN will be active as outlined in the message sent (either directly by EDEXIM or via the DNA) to the exporter to inform him on the validity of the RIN. The export can proceed upon expiry of the time period prescribed by Article 7(2) and as determined by the validity of the RIN. In the case of chemicals also listed in Parts 2 or 3 of Annex I, the RIN may not be activated because the explicit consent of the importing country needs to be obtained first — see Article 13. Annex 4: Workflow Chart 1 illustrates the Article 7 export notification procedure.

An export notification RIN will be valid from the date given by the exporter in the notification as the date of export or from the earliest possible date in compliance with the time limits prescribed by the Regulation. Export notification RINs are valid only until 31 December of the year for which the notification is made. A new export notification must be submitted, processed and sent to the importing country if another export is to be made during a subsequent year. In this case, the exporter must re-enter the export notification in EDEXIM and the Commission will send a new export notification to the importing country. A new export notification RIN is then issued and validated for that calendar year.

The Commission acts as common DNA for the European Union and it therefore sends and receives all export notifications on behalf of the Member States. Hence it is the Commission who requests confirmation of receipt of the export notifications. The Commission will send the notification for the first export from the EU of each chemical/preparation containing an Annex I chemical to the importing country no later than 15 days before the first export and then each year again before the first export that year. Even if the Commission has sent a prior notification to an importing country because of a notification from one exporter, other exporters are obliged to submit a notification before their first yearly export of the chemical concerned may proceed. A list of the chemicals concerned and the importing countries for each year will be kept available to the public at http://edexim.jrc.ec.europa.eu.

If the export relates to a public health or environmental emergency, where a delay could worsen the situation, the Member State (in consultation with the Commission) may decide to waive wholly or partly the waiting period or information requirements.

The government of the importing country may respond to an EU export notification by requesting further information. This information shall be provided by the exporter, the relevant DNA in the Member State concerned or the Commission. If the substance is a Part 1 substance or a substance of Part 2 and 3 for which a general explicit consent already exists, this does not affect the exporter’s right to export the chemical.

A new notification is required:

— when there is a change in EU legislation concerning the marketing and use or labelling of the chemical;

— when the composition of a preparation is changed insofar as the concentration of the chemical(s) concerned is different (for example to the extent that the required labelling is altered).

The new notification must indicate that it is a revision of a previous notification. This should be done by ticking the statement in the export notification form that indicates that the notification is a revision of a previous notification.

The Commission has to follow up notifications in cases where there is no acknowledgement of receipt from the importing country. If necessary, a second copy of the notification will be submitted. However again this has no direct impact on the export proceeding. Examples 1 and 3 of Section V illustrate the procedure for an export notification for substances listed in Part 1 of Annex I.

3.8. Article 8: EXPORT NOTIFICATIONS FROM THIRD COUNTRIES

When the Commission receives an export notification about a chemical from a third country, the marketing or use of which is banned or severely restricted in the country of origin, it registers this in the EDEXIM database. It acknowledges receipt of the first notification for each chemical from another country. The Commission forwards a copy of the notification and all available information to the DNA of the Member State receiving the import and, upon request, provides copies to other Member States.

In cases where a DNA in a Member State receives a notification, it must send it forthwith to the Commission, together with all relevant information.

3.9. Article 9: INFORMATION ON EXPORT AND IMPORT OF CHEMICALS

During the first quarter of each year, the exporter of:

— substances listed in Annex I;

— preparations containing Annex I substances in a concentration that triggers labelling obligations under Directive 1999/45/EC, or;

— articles containing substances listed in Parts 2 or 3 of Annex I in an unreacted form, or preparations containing such substances in a concentration that triggers labelling obligations under Directive 1999/45/EC

has to inform his DNA of the quantities of that chemical exported (as a substance, in preparations, and/or in articles) to each importing country for the previous year. Information should include a list of the names and addresses of each importer to which shipment took place. It should be noted that the definition of ‘article’ implies that information on export is only required if the use of the chemical in the particular article is banned or severely restricted by EU legislation, and not in all other articles where the substance might be used without restrictions.

Any exports of chemicals listed under Parts 2 and 3 of Annex I that proceed with the approval of the DNA of the exporter and of the Commission but in the absence of explicit consent from the importing Party or other country shall be listed separately (see Article 13(7)).

Importers have to provide the same information for quantities of chemicals placed on the internal market.

Any necessary additional information requested by the DNA or the Commission must also be provided.

The DNAs will compile and aggregate the information received from exporters and importers using the format set out in Annex III to the Regulation and will transmit it to the Commission. The Commission will then publish an overall summary of the non-confidential information on the Internet.

3.10. Article 10: PARTICIPATION IN THE PIC NOTIFICATION PROCEDURE

Chemicals that qualify for PIC notification (i.e. those banned or severely restricted in the European Union within a Convention use category) are included in Part 2 of Annex I. After inclusion, they must be notified by the Commission to the PIC Secretariat no later than 90 days after the relevant EU regulatory action has taken effect. The notification has to contain the information listed in Annex IV to the Regulation. If the Commission does not have this information at hand, it can require exporters/importers to provide such information within a 60 day timeframe. The notification has to be updated when there is a change in the regulatory action banning or severely restricting the chemical.

In determining priorities for notification, the Commission will take into account whether the chemical is already subject to the PIC procedure, the extent to which the information requirements of Annex IV to the Rotterdam Convention can be met, and the severity of the risks presented by the chemical, in particular for developing countries.

Member States may also submit, via the Commission, notifications of chemicals banned or severely restricted by national regulatory actions. In such cases it is required that the Member State concerned provides relevant information to the Commission, which will circulate this to all the other Member States. The latter have four weeks in which to comment. Ultimately, the submitting Member State decides whether or not to ask the Commission to forward the notification to the PIC Secretariat or to provide the information pursuant to Article 11.

When the Commission receives information about PIC notifications from other Parties to the Convention, it shall circulate these immediately to all Member States and, if appropriate, prepare the adoption of relevant EU measures. Furthermore, the information will be placed on the EDEXIM website at http://edexim.jrc.ec.europa.eu.

3.11. Article 11: INFORMATION TO BE SUBMITTED TO THE PIC SECRETARIAT ON CHEMICALS NOT QUALIFYING FOR PIC NOTIFICATION

Apart from PIC notification, the Regulation provides another means for disseminating information about banned or severely restricted chemicals, using the Convention’s provisions on exchange of information. These are relevant, for example, to chemicals that are banned or severely restricted within the European Union only in a use subcategory and thus do not qualify for PIC notification. They are also relevant to chemicals banned or severely restricted by national regulatory actions in one or more Member States when those Member States concerned conclude, following the consultation procedure referred to above, that PIC notification would not be appropriate.

In such cases, the Commission provides relevant information to the PIC Secretariat so that other Parties to the Convention can be made aware.

3.12. Article 12: OBLIGATIONS IN RELATION TO IMPORTS OF CHEMICALS

The Regulation requires Member States to control the import of chemicals listed in Annex I and to designate the authorities, e.g., customs, with this responsibility (13). While the Regulation does not include any detailed provisions on restrictions or prohibition at importation, it establishes a procedure through which the Commission, in close cooperation with the Member States, can evaluate and take import decisions regarding chemicals covered by the PIC procedure.

The Commission receives Decision Guidance Documents (DGDs) from the PIC Secretariat, which it circulates to the Member States. Within nine months of the date of dispatch of the DGD by the Secretariat, the Commission adopts a European Union import decision for the chemical concerned, and relating to the use category or categories for the chemical specified in the DGD. Before adopting the decision, the Commission obtains the opinion of the Member States using the advisory committee procedure via a vote in the committee established pursuant to Article 133 of Regulation (EC) No 1907/2006 (REACH).

Import decisions are based on already existing EU legislation and apply this legislation in the context of the Rotterdam Convention. The decision on whether a chemical is allowed to be imported and/or used and/or placed on the market of the EU territory is established by the EU legal act regulating the import, use or placing on the market of the chemical at stake, e.g. REACH or the legislation on plant protection products or biocidal products. Therefore, Regulation (EC) No 689/2008 does not include any detailed provisions as regards restrictions or prohibition at importation.

The import decision is communicated to the Rotterdam Convention Secretariat (14) and exporting Parties are requested to respect this decision.

The import decision is not addressed to Member States and does therefore not establish any rules Member States or operators have to comply with. The rules Member States and operators have to respect are established by the other relevant EU legislation. If the legislation is modified, or the regulatory status of a chemical otherwise changes (e.g. after completion of an evaluation within the framework of such legislation), the import decisions are revised.

Where relevant, the import decision will also mention different and more specific national rules if so requested in writing by the Member State(s) concerned. Import decisions will relate to the use category specified in the PIC Convention for the chemical concerned.

When evaluating the information contained in the DGD, the Commission and the Member States will consider the need to adopt EU measures and, where considered necessary to reduce risks to human health and the environment, the Commission will propose appropriate EU legislation.

3.13. Article 13: OBLIGATIONS IN RELATION TO EXPORTS OF CHEMICALS OTHER THAN EXPORT NOTIFICATION

EU exporters must comply with the import decisions (both interim and final) taken by third countries, which are published every 6 months in the ‘PIC Circular’ issued by the PIC Secretariat (and which are also made available on the Convention website at http://www.pic.int). The Commission forwards the PIC Circulars to the DNAs and industry associations. The Commission also keeps them publicly available in the EDEXIM database at http://edexim.jrc.ec.europa.eu. Import decisions are also available from the DNAs. The obligation to comply with an import decision starts 6 months after the Secretariat has distributed the information.

For the export of chemicals listed in Part 3 of Annex I for which the import decision published in the latest PIC Circular consents to the import, it is pursuant to Article 7(6) not necessary to notify the export, unless the importing Party requires otherwise. However, exporters have to provide a RIN (import decision reference identification number) in the customs declaration. This RIN can be obtained either by the administrative procedure known as a ‘special RIN request’ or by consulting the import decision database on EDEXIM. Since the import decision database does not exist yet, the other alternative should be used for the time being. Under the ‘special RIN request’ procedure, the exporter first checks if Article 13(6)(b) in conjunction with Article 7(6) applies to the export. If so, the exporter requests a special RIN from the exporting DNA. Provided that all requirements are met, the exporting DNA approves the request and activates the RIN, which has to be used by the exporter on the customs declaration (Annex 4: Workflow Chart 4 shows this procedure). The alternative procedure, which is not yet available, will allow the exporter to consult the import decision database on EDEXIM at http://edexim.jrc.ec.europa.eu, where he will find the RIN to be used in the customs declaration. The exporter has to ensure that his export complies with all requirements indicated in the import decision.

In many cases, importing countries fail to make a response to the PIC Secretariat or respond with an interim decision that does not address importation. With limited exemptions that are identified below, the Regulation therefore goes beyond the Convention and requires that the explicit consent of the importing country must be obtained before export takes place. Furthermore, this requirement applies not only to chemicals subject to the PIC procedure (i.e. those listed in Part 3 of Annex I to the Regulation), but also to those qualifying for PIC notification (i.e. listed in Part 2 of Annex I).

Explicit consent has to be sought and received through the exporter’s DNA and the DNA or other competent authorities in the importing country. It is advised that the exporter or importer should not make any direct contact with those authorities until after the exporter’s DNA has made a formal approach. Information on DNAs and (for non-parties) other relevant authorities is available on the EDEXIM website at http://edexim.jrc.ec.europa.eu. Where there are problems in identifying the authorities in the importing country, or when it is otherwise difficult to obtain a reply, the Commission may be able to assist. The DNA of the Member State of export should inform the Commission if it receives updated information on DNAs from third parties.

Should no response be received by either the Commission or the DNA of the exporter within 30 days of issuing the request, the Commission will send a reminder to the DNA of the importer. Additional reminders may be sent by the Commission, as necessary, in the absence of a response after a further 30 days. Annex 4: Workflow Chart 2 illustrates this procedure.

It is recommended that explicit consent be sought as far in advance of export as possible. A draft copy of the export notification (available on EDEXIM) would be a means of providing the necessary information to enable the importing country to take a decision. In order to facilitate the process for the DNA or other relevant authority in the importing country, it would be useful for exporters to submit copies to the DNA of the exporter of any registrations or authorisations which the importing country has issued for the chemical. The exporter DNA could then attach the documentation to the request for consent.

Explicit consent can take different forms. For example, it could be in the form of the official import decision transmitted via the Secretariat giving the importing country’s clear consent to imports (in the case of a chemical that is subject to the PIC procedure), or an email or letter of confirmation from the appropriate authorities in the importing country. Each document used as a basis for authorisation of an export of a chemical for which explicit consent is required gets a unique identifier (explicit consent identifier) and is stored on EDEXIM.

Once the explicit consent is received by a DNA for a substance or preparation, the DNA uploads it on EDEXIM. This ‘existing’ explicit consent can then be used by DNAs to approve export notifications and by the Commission to validate RINs for any subsequent request to the country in question, provided that no specific conditions are outlined in the original explicit consent response. Therefore DNAs should check EDEXIM to see if an applicable explicit consent response already exists. If so, there is no need for DNAs to request explicit consent from the country in question again. If the consent exists, the DNA should approve the export notification and forward it to the Commission without creating a new request for explicit consent. The Commission will check on EDEXIM whether a valid consent for the export already exists and, if so, will use the existing consent for validation of the RIN.

An explicit consent for a chemical remains valid for subsequent exports by any EU exporter for a period of three calendar years, unless otherwise specified in the explicit consent. Conditions specified by importing countries should be communicated by the DNA receiving the explicit consent to all exporters by posting them in the ‘notes’ field of the EDEXIM interface for exporters. At the end of the third year, a new request for explicit consent must be made to the DNA of the importing Party or the relevant authority of the other importing country by the DNA of the exporter and shall be channelled through the Commission. Pending response to the new request, exports of the relevant chemical may continue for a period of 12 months.

In the case of substances for which an explicit consent is required in addition to submitting an export notification (i.e. Part 2 chemicals and certain Part 3 chemicals for which an import decision does not exist), the validity of the explicit consent may vary and will in most cases be different from the validity of the RIN. By default, an explicit consent remains valid until the end of the third year from when it was obtained. However, the RIN will only remain valid until the 31 December of the year for which the notification was made, it will then be deactivated. In this case, a new export notification must be made during the subsequent year and a new RIN will be issued by the Commission. This new RIN will immediately be activated upon processing of the export notification, provided that all conditions are met. There will be no need to request a new consent until the explicit consent expires at the end of the third year from when it was obtained.

The Regulation provides for two possible exemptions to the requirement that explicit consent must be obtained prior to export of chemicals subject to the PIC Procedure or qualifying for PIC notification. Firstly, where a chemical qualifying for PIC notification (those listed in Part 2 of Annex I) is to be exported to OECD countries, (15) the requirement may be waived on a case-by-case basis. The decision to waive the requirement is to be taken by the DNA of the exporter in consultation with the Commission, the basis for the decision being that the chemical is, at the time of importation, licensed, registered or authorised in that OECD country. Annex 4: Workflow Chart 3 illustrates this procedure.

Secondly, a waiver may be granted on a case-by-case basis under Article 13(7), where, despite all reasonable efforts, no response has been received within 60 days of a request for an explicit consent for a chemical subject either to the PIC procedure or qualifying for PIC notification (chemicals listed in Parts 2 or 3 of Annex I). The decision to waive the requirement is taken by the DNA of the exporter in consultation with the Commission, and must be based on evidence from official sources in the importing Party or other country that the chemical in question is licensed, registered or authorised in that country. When deciding on the export of chemicals listed in Part 3 of Annex I, the decision must also take into consideration possible impacts on human health and the environment in the importing Party or other country. Such waivers can be granted for a maximum period of 12 months, after which time explicit consent is required, unless a response to the initial request for explicit consent has been received. After the maximum period of 12 months has expired, if no response to the request for explicit consent has been received, the exporter will once again need to seek explicit consent through the exporter’s DNA, which means that the above-mentioned procedure starts again from the beginning.

In order to increase the probability of getting a reply to a request for explicit consent, DNAs are encouraged to use as much as possible the official UN languages regime and to request explicit consent in whichever of these languages is the most relevant to the importing country. DNAs can find templates of explicit consent letters and response forms in the most common languages English (EN), French (FR) and Spanish (ES) in the ‘Explicit Consent’ section on the EDEXIM website available at http://edexim.jrc.ec.europa.eu.

Information detailing the chemicals for which explicit consent has been sought, responses obtained, and waivers granted will be forwarded by exporters’ DNAs and maintained in the EDEXIM database. Each document used as evidence (decision taken by importing country or alternative evidence used for a waiver) is identifiable within the EDEXIM database according to a unique identifier (explicit consent identifier) assigned to it. All requests for explicit consent are listed with relevant information, including their status, on EDEXIM and can be consulted by the DNAs in the other Member States. Non-confidential information shall be made publicly available on the Internet by the Commission.

It should be noted that the obligation to get explicit consent also applies to the export of preparations (i.e. mixtures under Regulation (EC) No 1272/2008) containing Annex I, Part 2 or Part 3, substances in concentrations that could trigger labelling obligations under Directive 1999/45/EC (16). This means that a separate explicit consent must be requested for each preparation and a separate explicit consent RIN is subsequently issued for each preparation. In an effort to facilitate implementation of this provision, the explicit consent request includes various questions for the DNA in the importing country to answer. One of these questions is: ‘- do you consent to the import of other preparations containing the same Annex I substance?’ In most cases the importing DNA answers ‘no’ to this question, which then triggers the need for a separate explicit consent request for any other preparation, whereas in case of a positive reply, DNAs and the Commission can directly approve exports of other preparations containing the substance.

Since a preparation includes more than one substance, it is necessary to check for each substance whether an obligation to obtain explicit consent exists. If at least one substance triggers that obligation, a request for explicit consent must be submitted. An importing country may give an unspecific reply that registered chemicals are allowed to be imported. If substance A of a preparation AB is listed in Annex I to Regulation (EC) No 689/2008 and is registered in the importing country, the export can proceed even if substance B is not registered, provided it is not listed in Annex I. The request for explicit consent was triggered by substance A, not substance B.

In addition to these obligations, there are requirements relating to the quality of exported products. An exporter must ensure that exported products are not exported within 6 months of their expiry date, when such a date exists or can be inferred from the production date, unless the chemical’s intrinsic properties render this impracticable. In the case of pesticides, the size and packaging of containers must be optimised to reduce the risks of creating obsolete stocks, and the label has to contain specific information about storage conditions and stability under the climatic conditions of the importing country. In addition, the exported pesticide must comply with the legally-established EU purity specification.

3.14. Article 14: EXPORTS OF CERTAIN CHEMICALS AND ARTICLES CONTAINING CHEMICALS

The export of articles (17) containing certain chemicals is also subject to the export notification requirements laid down in Article 7. These apply only to articles containing or including chemicals in non-reacted form (i.e. that could present a risk of leaching out): chemicals subject to the PIC procedure, chemicals that have been banned or severely restricted by EU legislation when their use is restricted in that particular article, or preparations containing such substances in a concentration that could trigger labelling obligations under Directive 1999/45/EC or Regulation (EC) No 1272/2008 (18).

Furthermore the export of certain chemicals and articles listed in Annex V to the Regulation, the use of which is completely prohibited in the European Union, is not allowed. Annex V currently comprises mercury-containing soaps and 10 chemicals or groups of chemicals listed in the Stockholm Convention on Persistent Organic Pollutants (POPs) in accordance with the provisions therein, and is included in Annex 3 of this Guide. Future decisions taken under the Stockholm Convention could lead to more chemicals and articles being listed in Annex V.

3.15. Article 15: INFORMATION ON TRANSIT MOVEMENTS

In the case where a Party to the Convention requires information on transit movements of a chemical subject to the PIC procedure, the exporter must as far as practicable provide his DNA with the information laid down in Annex VI to Regulation (EC) No 689/2008 30 days before the first transit movement is due to take place, and at least 8 days before each subsequent movement. The DNA will forward the information, together with any available additional information, to the Commission, which will forward it to the DNA in the requesting importing Party no later than 15 days before the first transit movement and prior to each subsequent movement. Currently, no Parties to the Convention have indicated that they require such information.

3.16. Article 16: INFORMATION TO ACCOMPANY EXPORTED CHEMICALS

Exporters of all dangerous chemicals, as defined by EU legislation, must package and label their products in the same way as if they were to be marketed in the European Union unless the importing country has its own specific requirements, taking into account also relevant international standards.

The relevant EU rules are laid down in the following legal acts:

— Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (19);

— Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (20).

— Council Directive 91/414/EEC of 15 July 1991 concerning the placing of plant protection products on the market (21).

— Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on the market (22).

— Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (23).

The information on the label should include inter alia the following information:

— the trade name or designation of the preparation;

— the name, full address and telephone number of the person established in the Union who is responsible for placing the preparation on the market, whether it be the manufacturer, the importer or the distributor;

— a standard danger symbol (or pictogram) or appropriate combination of symbols and the indication(s) of danger;

— standard ‘R-phrases’ (or hazard statements) describing special risks arising from the dangers involved in using the substance;

— standard ‘S-phrases’ (or precautionary statements) describing safety requirements and emergency response procedures relating to the safe use of the substance;

— the identity of the substance or the substances in a preparation (or mixture), according to an international system of nomenclature.

It should be noted that the above list is not exhaustive and that detailed legal requirements are provided in Article 10 of Directive 1999/45/EC and in Article 17 of Regulation (EC) No 1272/2008, which also establishes new requirements for the information to be provided on the label. Those new requirements as well as the replacement of the danger symbols and the standard phrases by the GHS hazard pictograms and statements apply as of 1 December 2010 for substances and 1 June 2015 for mixtures. Regulation (EC) No 1272/2008 also provides for the term ‘mixtures’ replacing the term ‘preparations’.

The standard danger symbols used in the European Union:

The above standard danger symbols will be replaced by the GHS hazard pictograms pursuant to Regulation (EC) No 1272/2008, which implements the Globally Harmonised System of Classification and Labelling. The GHS hazard pictograms are provided below:

Annex V to Regulation (EC) No 1272/2008 contains the complete list of the CLP/GHS hazard pictograms for each hazard class and hazard category, if applicable. It is available at http://ec.europa.eu/enterprise/sectors/chemicals/documents/classification/index_en.htm.

Pursuant to the PIC Regulation, the information on the label also has to include the expiry date (for different climate zones if necessary) and the production date, where appropriate.

In addition, a safety data sheet must be sent to each importer with the chemical. The safety data sheet must be in accordance with Article 31 of and Annex II to Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (24).

The information on the label and on the safety data sheet shall, as far as practicable, be given in the official languages, or in one or more of the principal languages, of the country of destination or of the area of intended use (see Annex 6 to this guide for a list of languages) (25).

3.17. Article 17: OBLIGATIONS OF MEMBER STATES AND EXPORTERS FOR CONTROLLING IMPORT AND EXPORT

The Member States have to designate authorities such as customs offices to control imports and exports of chemicals listed in Annex I. They and the Commission shall coordinate their enforcement activities in relation to exporters and Member States have to regularly report on such activities. It should be noted that restrictions on imports result from relevant EU legislation, e.g. Regulation (EC) No 1907/2006 (REACH), Directive 91/414/EEC or Directive 98/8/EC (for details see guidance on Article 12).

Exporters are obliged to include the relevant reference identification number (RIN) in their customs declarations for export notifications, import decisions and explicit consents received as well as waivers relevant to exports of listed chemicals. This information should be entered either in box 44 of the Single Administrative Documents (SAD), or in the corresponding data element in an electronic export declaration, as completed under Council Regulation (EEC) No 2913/92 of 12 October 1992 establishing the Community Customs Code (26).

Please note that Y915 is the TARIC code which indicates the requirement for a RIN. If the code Y915 is contained in Box 44 of the SAD, it should be accompanied by a RIN. Hence Box 44 should contain Y915 and RIN. There are other related TARIC measures associated with the PIC Regulation and these are listed below:

— Y916 - This measure indicates that the chemical to be exported is not subjected to the provisions of Regulation (EC) No 689/2008 Annex I (relating to restrictions on export). No restriction applies.

— Y917 - This measure indicates that the chemical to be exported is not subject to the provisions of Regulation (EC) No 689/2008 Annex V (relating to prohibitions on the export of certain chemicals). No prohibition applies.

— Y919 - This measure indicates that the chemical to be exported is subjected to the provisions of Article 2(2)(i) of Regulation (EC) No 689/2008 which exempts the export from all provisions subject to the condition that the chemical is exported for the purpose of research or analysis in quantities not more than 10 kg.

In the case of Y919, this should be accompanied by a ‘Special RIN’ (see below).

If a RIN is entered in Box 44, customs should consult the customs interface of EDEXIM and check the status of the export. If the RIN is active for the export in question, the export should be cleared as normal. Where customs officers identify any problem regarding the TARIC code or the RIN provided in Box 44, the export should not be allowed to proceed and the chemicals must be taken back by the exporter.

The special administrative procedure known as a ‘special RIN request’, which has been set up to facilitate certain exports, is also used for exports falling within the Article 2.2(i) exemption, i.e., Annex I or Annex V substances for research and analysis in quantities of 10 kg or less. Under the ‘special RIN request’ procedure, the exporter first checks if Article 2.2(i) applies to the export. If so, the exporter requests a special RIN from the exporting DNA. Provided that Article 2.2(i) applies, the exporting DNA approves the request and activates the RIN, which should be used by the exporter on the customs declaration. Annex 4: Workflow Chart 4 shows this procedure.

3.18. Article 18: PENALTIES

The Member States must ensure correct implementation of the Regulation and have a system of penalties for non-compliance that are effective, proportional and dissuasive. Information regarding penalties must be made available upon request.

3.19. Article 19: INFORMATION EXCHANGE

The Commission and the Member States are to facilitate the provision of information to other countries about the chemicals subject to the Regulation. The Regulation acknowledges the need for certain confidentiality safeguards. However the following information may not be regarded as confidential:

— the information specified in Annex II (the export notification information requirements) and Annex IV (the PIC notification information requirements);

— the information contained in the safety data sheet;

— the expiry date of the chemical;

— the production date of the chemical;

— information on precautionary measures, including hazard classification, the nature of the risk and the relevant safety advice;

— the summary results of toxicological and ecotoxicological tests;

— information concerning handling of packaging after chemicals have been removed.

3.20. Article 20: TECHNICAL ASSISTANCE

The Commission and the Member States are to cooperate in promoting technical assistance, in particular with a view to enabling developing countries and countries with economies in transition to implement the Convention.

3.21. Article 21: MONITORING AND REPORTING

Article 21 is a standard article in EU legislation establishing monitoring and reporting requirements on the functioning and implementation of the Regulation.

Both the Member States and the Commission will monitor developments under the Regulation. The Member States must regularly send information on the operation of the various procedures to the Commission, which must regularly report to the European Parliament and to the Council on the overall functioning of the Regulation. Again, there are provisions to protect commercial confidentiality.

3.22. Article 22: UPDATING ANNEXES

Updating of Annexes will be decided by the regulatory committee procedure with scrutiny. Under this procedure, Commission proposals pass through the Committee composed of representatives of Member States, before being submitted to the Council and the European Parliament for scrutiny. A negative opinion of either would oblige the Commission to submit an amended proposal of the measure to the Committee or to present a legislative proposal that would have to be adopted by the co-decision procedure.

Annex I will be reviewed at least every year. When new chemicals are included in the various parts of Annex I this will then trigger as appropriate export notification requirements, submission of a PIC notification, explicit consent for export requirements, and the obligation to respect other countries’ import decisions for chemicals subject to the PIC procedure.

The following measures to update Annexes have to be adopted by the same procedure:

— inclusion of a chemical subject to Regulation (EC) No 850/2004 of the European Parliament and of the Council of 29 April 2004 on persistent organic pollutants (27) in Part 1 of Annex V;

— amendment of Annex I, including modifications to existing entries;

— inclusion of a chemical already subject to an export ban at EU level in Part 2 of Annex V;

— amendment of Annexes II, III, IV and VI; and

— measures to modify existing entries in Annex V.

Inclusion of substances or articles not yet banned for export into Annex V Part 2 (meaning a ban of exports) will necessitate a co-decision by the European Parliament and the Council upon a proposal by the Commission.

3.23. Article 23: TECHNICAL NOTES FOR GUIDANCE

In order to assist in implementation, the Commission is to draw up technical notes for guidance, of which this guide is an example. All guidance will be made publicly available on EDEXIM.

3.24. Article 24: COMMITTEE

The Commission shall be assisted by the committee established by Article 133 of Regulation (EC) No 1907/2006. Its main tasks are vote on proposed EU import decisions (Article 12) and proposed amendments to the Annexes to the Regulation (Article 22).

4. THE EUROPEAN DATABASE ON EXPORT AND IMPORT OF DANGEROUS CHEMICALS

Many tasks relating to the day-to-day implementation of Regulation (EC) No 689/2008 are carried out by means of the European Database EXport IMport of dangerous chemicals (EDEXIM). The database is an important tool for processing and management of legal requirements as well as for information exchange and is used by European stakeholders involved in the respective activities. In addition, stakeholders from third countries can use EDEXIM as a source of information on this matter.

EDEXIM is permanently being upgraded due to the increasing numbers of notifications to process and because of an increasing demand for additional features to facilitate the day-to-day work of stakeholders. Currently there are five interfaces to the database:

— an interface available to the general public, which provides non-confidential information;

— the DNA interface for use by Member States, to manage implementation of Regulation (EC) No 689/2008, in particular export notifications (Article 7) and requests for explicit consent (Article 13);

— the exporters interface used by EU exporters to notify (and subsequently follow-up) planned exports and provide necessary information in accordance with the legal requirements of Regulation (EC) No 689/2008 and thereby speed up procedures;

— the customs interface, designed to assist customs in controlling trade in dangerous chemicals;

— the administrative interface (used by the Commission) for processing and storing import and export notifications as well as performing basic website maintenance.

The main objective of EDEXIM is to serve as a platform for processing of legal requirements and to provide the user with information on the implementation of Regulation (EC) No 689/2008 within the European Union related to:

— export notification for chemicals listed in Annex I to the Regulation,

— import decisions taken by countries on request for chemicals listed in Part 2 or 3 of Annex I to the Regulation; and

— import decisions made by countries participating in the international PIC procedure under the Rotterdam Convention for chemicals listed in Part 3 of Annex I to the Regulation.

The exporters interface allows exporters to notify their DNAs directly and on-line of planned exports of Annex I chemicals. Once the exporter has created and saved an export notification, an inactive export reference identification number (RIN) is assigned to the export. After submission by the exporter, the DNA will handle the export notification without undue delay and, if complete and correct, forward it to the Commission. EDEXIM notifies the exporter when the DNA has submitted the notification to the Commission. By inserting the RIN in ‘Search Activation Status by RIN’ the exporter can monitor the processing status of his notification. It also informs the exporter after final approval of the notification, including the period of validity of the notification. For substances not requiring an explicit consent, the RIN will be active (i.e. the export will be allowed) as from the export date indicated by the exporter or the earliest possible date in compliance with the time limits prescribed by the Regulation. For those exports where explicit consent is required, the RIN will only be activated if the respective conditions are met.

The EDEXIM system also assigns each explicit consent an internal identification number, i.e. the explicit consent reference identification number (or in short explicit consent identifier) which is associated to the notification during processing. When a DNA posts an explicit consent on EDEXIM, EDEXIM informs the Commission so that it can process the explicit consent. DNAs and the Commission have access to the list of explicit consents.

If there is no explicit consent, EDEXIM will notify the exporter that the export is not allowed.

The interface available to the general public of EDEXIM provides facilities such as: a check for existing export notifications for the first annual export of certain dangerous chemicals to the country of destination; information on classification and labelling requirements of dangerous chemicals subject to the Regulation and preparations containing those chemicals; information on third country import decisions for chemicals listed in Part 2 or 3 of Annex I to Regulation (EC) No 689/2008 and statistics on registered export notifications from the European Union.

In an effort to facilitate procedures for the exporter, EDEXIM works on the basis of one single reference identification number obtained either by submitting a notification or by submitting a special RIN request. Submission of a notification is mandatory for Annex I Part 1 and Part 2 chemicals and for Annex I Part 3 chemicals for which no import decision exists. For Annex I Part 3 chemicals for which an import decision that consents to the import is published in the PIC Circular, two options are intended to be available for getting the RIN that has to be provided in the customs declaration: 1) to submit a special RIN request via EDEXIM or 2) to consult the import decision database on EDEXIM. Since the import decision database is not yet available exporters should use the other option for the time being. A special RIN request should also be made for all exports falling under the Article 2.2(i) exemption, i.e., Annex I or Annex V substances for research and analysis in quantities of 10 kg or less.

The use and terminology of the reference identification numbers is for practical reasons different from Regulation (EC) No 689/2008. The details are as follows:

The export reference identification number mentioned in the Regulation equals the reference identification number obtained by submitting an export notification.

The explicit consent reference identification number mentioned in the Regulation equals the explicit consent identifier used by EDEXIM for identification of each explicit consent and waiver. There is no need to provide this number in the customs declaration since the relevant explicit consent is attached to the export notification and can be identified via the RIN.

The import decision reference identification number is a RIN obtained either by the special RIN request for Annex I Part 3 chemicals for which an import decision that consents to the import is published in the PIC Circular or by consulting the import decision database on EDEXIM (please note that the import decision database is not yet available).

5. EXAMPLES

The following examples outline the steps to be taken by exporters in a number of possible scenarios. The scenarios are based on the assumption that the exporter uses EDEXIM for export notification, since this is already common practice. Example 1 outlines several requirements concerning the information to be provided in customs declarations and to DNAs, as well as packaging and labelling obligations that must be respected whenever Annex I chemicals are exported. To avoid repetition, these requirements are not detailed in full after Example 1 but simply referenced.

First, an exporter of an Annex I chemical will be allocated a reference identification number (RIN) by EDEXIM and must include this reference identification number in his customs declaration. Secondly, during the first quarter of the next year the exporter must report to his DNA the quantities of chemicals, i.e. Annex I chemicals, certain preparations containing Annex I substances and certain articles containing substances listed in Parts 2 or 3 of Annex I, which the exporting company shipped pursuant to Regulation (EC) No 689/2008 and the names and addresses of each importer to which shipment took place.

Finally, exporters of all dangerous chemicals, as defined by EU legislation, must package and label their products according to EU legislation. In addition, a safety data sheet must be sent to each importer with all information provided as far as practicable in the official language used in the importing country and in English.

Example 1

A manufacturer in one of the EU Member States intends to export for the first time hexachloroethane to country A. Hexachloroethane is listed in Part 1 of Annex I to the Regulation since it is severely restricted for industrial use. It appears that the chemical has not previously been exported from the EU to country A.

— The exporter must submit an export notification via EDEXIM supplying the information set out in Annex II to the Regulation to his Designated National Authority (DNA) at least 30 days before the export. EDEXIM assigns the export notification an inactive reference identification number (RIN).

— Having established that the export notification is complete, the DNA promptly forwards the export notification to the Commission. Having verified that no EU export notification has already been made for that calendar year, the Commission sends the export notification to country A. If an export notification has been made for that year, the export notification is stored in EDEXIM without being sent.

— The exporter will be informed by EDEXIM that the export notification has been processed and that the RIN will be activated (i.e. export can take place) as from the expected date of export which was declared on the export notification. The RIN must be included in the customs declaration.

— The chemical must be packaged and labelled as it has to be in the EU, except where the importing country requires otherwise. The exporter shall send a safety data sheet to the importer.

— The label and safety data sheet should be printed in English and the official language used by country A (see Annex 6 for further guidance on languages).

— Where appropriate, the expiry and production dates shall be indicated on the label, which should also contain specific information on storage conditions and stability under the climatic conditions of country A. The chemical should not be exported later than six months before the expiry date.

— In addition, the size and packaging of the pesticide containers should be optimised so as to minimise the risks of creating obsolete stocks.

— During the first quarter of the next year, the EU manufacturer shall inform its DNA of the quantities of the chemical shipped to country A during the preceding year.

Example 2

Company Chemoproducts wants to ship boron trichloride to country B. Boron trichloride is not listed in Annex I to the Regulation, but was classified as a dangerous chemical under Directive 67/548/EEC and is classified as a hazardous chemical in Annex VI to Regulation (EC) No 1272/2008 (28).

— The exporter does not need to provide any information to his DNA. The export may take place without export notification or consent from the importing country.

— The requirements relating to packaging and labelling of exports, the expiry date of the chemicals, and the provision of safety data sheets apply, as outlined in Example 1.

Example 3

ABC Chemicals intends to export chloroform to country C. Chloroform is listed in Part 1 to Annex I to the Regulation and has been exported to country C by another company earlier in the year, but was never exported by ABC Chemicals before.

— The exporter must submit an export notification supplying the information set out in Annex II to the Regulation to his Designated National Authority (DNA) at least 30 days before the export.

— After having saved and submitted the export notification, the exporter gets the RIN, which is not activated at this stage.

— Having established that the export notification is complete and correct, the DNA forwards the export notification to the Commission. The Commission checks the notification and approves it, which activates the RIN for the export as from the expected date of export. Given that an EU export notification has already been made for that calendar year, the export notification is stored in EDEXIM without being sent to the importing country.

— The requirements relating to the information to be provided in customs declarations and to the relevant DNA, as well as to packaging and labelling of exports, the expiry date and containers, and the provision of safety data sheets apply, as outlined in Example 1.

Example 4

Company LongShip intends to export PCTs to country D, which is a Party to the Convention. PCTs are subject to the PIC procedure under the Rotterdam Convention and therefore listed in Parts 1 and 3 of Annex I to the Regulation. Country D has reported an import decision in the latest update of the PIC Circular, giving consent.

— The exporter does not need to submit an export notification and can proceed with the export provided that the expected use in the importing country corresponds to the category for which the substance was listed in Annex III to the Convention.

— It is recommended that the exporter makes a request for a special RIN (either to his DNA who will insert it in EDEXIM or directly via EDEXIM) and that he provides this RIN in the customs declaration. Alternatively, the exporter could consult the import decision database on EDEXIM in order to get the RIN that needs to be provided in the customs declaration. It should be noted that the import decision database is not yet available.

— The requirements relating to the information to be provided in customs declarations and to the relevant DNA, as well as to packaging and labelling of exports, the expiry date and containers, and the provision of safety data sheets apply, as outlined in Example 1.

Example 5

Company KillingPest, based in one of the EU Member States, intends to import parathion from country E to produce a pesticide, and then export the preparation to country F. Parathion is banned in the EU for use as a pesticide (both as plant protection product and as biocide). The substance is listed in Part 1 of Annex I to the Regulation as well as Part 3 (being subject to the PIC procedure in the pesticides category). In the latest PIC circular the import decision for the EU is ‘no consent’ for the pesticide use category. The import decision for country F is ‘consent’.

— Notwithstanding the EU import decision, the company may import the substance for industrial processing to produce a pesticide as this will not be marketed within the EU.

— Since country F has given consent to import, the export may proceed. There is no need for an export notification.

— It is recommended that the exporter makes a request for a special RIN (either to his DNA who will insert it in EDEXIM or directly via EDEXIM) and that he provides this RIN in the customs declaration. Alternatively, the exporter could consult the import decision database on EDEXIM in order to get the RIN that needs to be provided in the customs declaration. It should be noted that the import decision database is not yet available.

— The requirements relating to the information to be provided in customs declarations and to the relevant DNA, as well as to packaging and labelling of exports, the expiry date and containers, and the provision of safety data sheets apply, as outlined in Example 1.

Example 6

An exporter wishes to export for the first time chlordimeform to country G, which is a Party to the Convention. Chlordimeform is listed in parts 1 and 3 of Annex I to the Regulation since it is subject to the PIC procedure in the pesticide category. No import decision for country G is listed in the latest PIC circular.

— The exporter must submit an export notification supplying the information set out in Annex II to the Regulation to his Designated National Authority (DNA) at least 30 days before the export.

— After having saved and submitted the export notification, the exporter gets the RIN, which is not yet activated at this stage.

— The export cannot proceed unless the DNA in country G has given its explicit consent to import of chlordimeform. If the exporter’s DNA establishes from EDEXIM that no such consent already exists, the exporter’s DNA will have to seek this consent from the DNA in country G (the Commission is ready to help if needed).

— If, despite all reasonable efforts, no response is received within 60 days, and if there is documentary evidence that chlordimeform is registered or authorised in country G for pesticidal use, the exporter’s DNA may in consultation with the Commission decide that the export can proceed. However, authorisation for exports can only be granted for a maximum period of 12 months, upon expiry of which explicit consent from country G will have to be requested again. The conditions outlined in this paragraph also apply to Example 7 below.

— Depending on the final result of the request for explicit consent procedure, the export may be allowed and the RIN may be activated by the Commission. Otherwise the RIN will stay inactive.

— Annual export notification by the exporter will continue to be required, even if explicit consent is obtained, unless country G waived its right to receive such notifications.

— Should the export proceed, either under an explicit consent or under a waiver, the requirements relating to the information to be provided in customs declarations and to the relevant DNA, as well as to packaging and labelling of exports, the expiry date and containers, and the provision of safety data sheets apply, as outlined in Example 1.

Example 7

Company Buy and Sell wants to export for the first time a pesticide containing nitrofen to country H. Nitrofen is listed in Parts 1 and 2 of Annex I to the Regulation. It is banned for plant protection use within the EU and the relevant regulatory action has been notified to the PIC Secretariat. Country H is a Party to the Convention. However since the chemical is not subject to the PIC procedure, no import decision for the chemical exists.

— The exporter must submit an export notification supplying the information set out in Annex II to the Regulation to his Designated National Authority (DNA) at least 30 days before the export.

— After having saved and submitted the export notification, the exporter gets the RIN, which is not yet activated at this stage.

— As with Example 6 above, the export cannot proceed unless the DNA in country H has given its explicit consent to importing nitrofen. The difference is that since the chemical is not subject to the PIC Procedure, an import decision is certainly not published in the latest PIC Circular. The same conditions as outlined in Example 6 apply, including the requirement to seek explicit consent, the possibility of requesting a time-limited waiver, and the need for explicit consent thereafter.

— Depending on the final result of the request for explicit consent procedure, the export may be allowed and the RIN may be activated by the Commission. Otherwise the RIN will stay inactive.

— Should the export proceed, the requirements relating to the information to be provided in customs declarations and to the relevant DNA, as well as to packaging and labelling of exports, the expiry date and containers, and the provision of safety data sheets apply, as outlined in Example 1.

— Annual export notification by the exporter will continue to be required, even if explicit consent is obtained, unless country H waived its right to receive such notifications.

Example 8

Company Exterminator wishes to export dimethenamid to country I, which is an OECD country. Dimethenamid is banned in the EU for use as a pesticide. It is listed in Parts 1 and 2 of Annex I to the Regulation and therefore, explicit consent from the importing country would normally be required. Since the chemical is not subject to the PIC procedure, no import decision for the chemical exists.

— The exporter must submit an export notification supplying the information set out in Annex II to the Regulation to his Designated National Authority (DNA) at least 30 days before the export.

— After having saved and submitted the export notification to the DNA, the exporter gets the RIN, which is not yet activated at this stage.

— If considered complete and correct, the export notification is forwarded to the Commission by the DNA. If no EU export notification has been made yet for that calendar year, the Commission forwards it to country I. If an export notification has been made for that year, the export notification is stored in EDEXIM without being sent.

— Dimethenamid is listed in part 2 of Annex I and consequently the export cannot proceed unless explicit consent to import has been sought and received. However, since the country I is an OECD country, the DNA may consider applying a waiver and may, therefore, request the exporter to provide documentary evidence that the substance is licensed, registered or authorised. Provided that this evidence was presented, the DNA may decide in consultation with the Commission that the export can proceed without the explicit consent of the importing country.

— However, if the DNA, in consultation with the Commission, decides that explicit consent is required, an explicit consent to importation must be obtained from the DNA in country I, as per example 7 above.

— Depending on the final result of the request for explicit consent procedure, the export may be allowed and the RIN may be activated by the Commission. Otherwise the RIN will stay inactive.

— The requirements relating to the information to be provided in customs declarations and to the relevant DNA, as well as to packaging and labelling of exports, the expiry date and containers, and the provision of safety data sheets apply, as outlined in Example 1.

— Annual export notification by the exporter will continue to be required, even if explicit consent is obtained, unless country I waives its right to receive such notifications.

Example 9

Company XYZ intends to export 1,2-dibromoethane (EDB) to country J for industrial use. EDB is listed in Parts 1 and 3 of Annex I to the Regulation. It is banned for plant protection use within the EU and is listed in the PIC procedure in the pesticides category. In the latest PIC circular the import decision for country J is ‘consent’ for use as a pesticide.

— Since the substance is subject to the PIC procedure for pesticide use but not for industrial use, country J has not established a decision giving consent to import of EDB for industrial uses. Consequently, the exporter must submit an export notification and must obtain explicit consent to import for industrial use. In order to do so, the same procedure as outlined in examples 6 or 7 should be followed.

— The requirements relating to the information to be provided in customs declarations and to the relevant DNA, as well as to packaging and labelling of exports, the expiry date and containers, and the provision of safety data sheets apply, as outlined in Example 1.

Example 10

Company Pest Products intends to export a fungicide preparation containing pentachlorophenol (60 % active ingredient), Fungicide X, to country K. Pentachlorophenol is listed in Parts 1 and 3 of Annex I to the Regulation, being subject to the PIC procedure in the pesticides category. Country K is not a Party to the Convention so there are no import decisions for that country listed in any PIC circular. Another EU company has exported another preparation (with 30 % pentachlorophenol) earlier in the year having obtained through his DNA the explicit consent of country K’s authorities. The explicit consent does not cover all preparations containing pentachlorophenol, only that particular preparation.

— The exporter must submit an export notification supplying the information set out in Annex II to the Regulation to his DNA at least 30 days before the export. This will be forwarded to the Commission, which will submit it as an EU export notification.

— However the export cannot proceed until the appropriate authorities in country K give a further explicit consent in respect of Fungicide X since the existing explicit consent was limited to a different formulation. To obtain such consent, the same procedure as outlined in examples 6 or 7 should be followed.

— The requirements relating to the information to be provided in customs declarations and to the relevant DNA, as well as to packaging and labelling of exports, the expiry date and containers, and the provision of safety data sheets apply, as outlined in Example 1.

Example 11

Company Laboratory Analysis Products intends to export 100 g nitrofen for use in analysis in a laboratory to country L. Nitrofen is listed in Parts 1 and 2 of Annex I to the Regulation, and therefore explicit consent from the importing country would normally be required. Since the quantity of nitrofen intended to be exported in 2011 to country L is less than 10 kg and not considered likely to affect health or the environment as it is used under laboratory conditions for analysis, the export falls under Article 2.2(i) of Regulation (EC) No 689/2008 and is therefore exempted from the Regulation. However, in order to avoid difficulties at customs clearance a special procedure was established to get an activated RIN.

— It is recommended that the exporter submits via EDEXIM a special RIN request to his DNA some time before the export is intended to take place. After approval by the DNA, the exporter will get an activated RIN.

— The exporter should include the RIN in his customs declaration.

(1) OJ L 204, 31.7.2008, p. 1.

(2) OJ L 63, 6.3.2003, p. 1.

(3) Regulation (EC) No 304/2003 was annulled by the Court of Justice of the European Union in 2006, for being based solely on Article 175(1) (Environment) of the Treaty, whereas it should have been founded on two legal bases, namely Article 133 (Common Commercial Policy) in addition to Article 175 (Case C-178/03 (Commission v Parliament and Council)).

(4) OJ L 353, 31.12.2008, p. 1.

(5) OJ L 196, 16.8.1967, p. 1, Directive 67/548/EEC will be fully repealed by Regulation (EC) No 1272/2008 with effect from 1 June 2015.

(6) OJ L 200, 30.7.1999, p. 1, Directive 1999/45/EC will be fully repealed by Regulation (EC) No 1272/2008 with effect from 1 June 2015.

(7) OJ L 63, 6.3.2003, p. 27.

(8) OJ L 230, 19.8.1991, p. 1.

(9) OJ L 309, 24.11.2009, p. 1.

(10) OJ L 123, 24.4.1998, p. 1.

(11) OJ L 396, 30.12.2006, p. 1.

(12) These chemicals are listed in Annex 3 to this Guide (Annex V to the Regulation).

(13) See Article 17 of the Regulation.

(14) The decision is also made available to the public, in particular those concerned, by the DNAs in the Member States. It is also published in the regular ‘PIC Circular’, produced by the PIC Secretariat (see below) and on the PIC website at http://www.pic.int.

(15) See Annex 8 to this Guide for a list of OECD countries.

(16) Please note that Directive 1999/45/EC will be fully repealed by Regulation (EC) No 1272/2008 with effect from 1 June 2015.

(17) Defined in Article 3.

(18) Please note that Directive 1999/45/EC will be fully repealed by Regulation (EC) No 1272/2008 with effect from 1 June 2015.

(19) OJ L 196, 16.8.1967, p. 1, Directive 67/548/EEC will be fully repealed by Regulation (EC) No 1272/2008 with effect from 1 June 2015.

(20) OJ L 200, 30.7.1999, p. 1, Directive 1999/45/EC will be fully repealed by Regulation (EC) No 1272/2008 with effect from 1 June 2015.

(21) OJ L 230, 19.8.1991, p. 1, Directive 91/414/EEC will be fully repealed by Regulation (EC) No 1107/2009 with effect from 14 June 2011.

(22) OJ L 123, 24.4.1998, p. 1.

(23) OJ L 353, 31.12.2008, p. 1.

(24) OJ L 396, 30.12.2006, p. 1.

(25) Please refer to the website of the European Chemicals Agency for more guidance on the CLP Regulation and its requirements on labelling and saftey data sheets: http://echa.europa.eu/clp/clp_help_en.asp

(26) OJ L 302, 19.10.1992, p. 1.

(27) OJ L 229, 30.4.2004, p. 5.

(28) Please note that Directive 67/548/EEC will be fully repealed by Regulation (EC) No 1272/2008 with eff