Explanatory Memorandum to COM(2006)745 - Export and import of dangerous chemicals

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dossier COM(2006)745 - Export and import of dangerous chemicals.
source COM(2006)745 EN
date 30-11-2006
CONTEXT OF THE PROPOSAL

- Grounds for and objectives of the proposal

Regulation (EC) No 304/2003 of the European Parliament and of the Council of 28 January 2003 concerning the export and import of dangerous chemicals Community i ('the Regulation') implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.

On 10 January 2006, in its judgment in case Commission v . Parliament and Council i, the Court of Justice annulled the Regulation, ruling that there should have been a dual legal basis including both Articles 133 and 175 first paragraph of the Treaty. The Court however maintained the effects of the Regulation until the adoption, within a reasonable period of time, of a new regulation founded on appropriate legal bases.

The purpose of this proposal is therefore a new Regulation, based on the above-mentioned dual legal basis. At the same time, it is proposed to include certain technical amendments to the operative provisions in the light of a Commission report in accordance with Article 21 of the Regulation on the experience of the procedures to date. That report is being submitted in parallel to this proposal.

- General context

The Rotterdam Convention was adopted in September 1998. It entered into force on 24 February 2004.

In January 2002, the Commission put forward a proposal, based on Article 133 of the Treaty, for a Council Regulation concerning the export and import of dangerous chemicals to implement to the provisions of the Convention within the Community.

After the European Parliament had been consulted on an optional basis pursuant to Article 133, the Council unanimously decided to replace Article 133 by Article 175 i. The Parliament and the Council subsequently jointly adopted Regulation (EC) No 304/2003 of 28 January 2003 concerning the export and import of dangerous chemicals.

Article 21 of the Regulation requires that the Member States shall regularly forward to the Commission information on the operation of the procedures provided for in the Regulation. The Commission shall compile this information in a synthesis report integrating also a report on the performance of the functions provided for in the Regulation for which it has responsibility. The first such overall summary report covering the period from entry into force of the Regulation up until the end of 2005 has recently been compiled. The overall conclusion of the report, confirmed by regular consultations of the Member States, industry and other NGOs, is that generally the procedures are working well, but that certain technical amendments are warranted.

In addition to annulling the Regulation, in a parallel judgment i, the Court annulled for the same reasons Council Decision 2003/106/EC of 19 December 2002 on the approval, on behalf of the European Community, of the Convention i.

Although the annulment of that Council Decision does not affect the original Community ratification of the Convention, a new Council Decision is required with the dual legal base together with an amended declaration of competence to be delivered to the UN depositary. The Commission recently put forward a separate proposal to that end, which was adopted by the Council on 25 September 2006 (Decision 2006/730/EC i).

- Existing provisions in the area of the proposal

As noted above, the current Community rules relating to the export and import of dangerous chemicals are laid down in Regulation (EC) No 304/2003, as most recently amended by Commission Regulation (EC) No 777/2006 i.

The Regulation goes significantly beyond the requirements of the Convention. The key differences can be summarised as follows:

- the rules apply to exports to all countries, whether or not they are Parties to the Convention;

- a wider range of chemicals are subject to annual export notification. For the purposes of determining which chemicals should be subject to the procedure, the two Convention use categories (pesticides and industrial chemicals) are divided into two subcategories each ( plant protection products and other pesticides such as biocides; and chemicals for professional use and chemicals for consumer use). Moreover export notification has to be made irrespective of the chemical's intended use and whether or not that use is banned or severely restricted in the EU. Furthermore chemicals subject to the international PIC procedure ('PIC chemicals') and certain articles are also covered;

- PIC chemicals and chemicals that are banned or severely restricted in the Community in a Convention use category cannot be exported without the explicit consent of importing countries;

- Certain articles and chemicals (such those chemicals that are subject also to the Stockholm Convention on Persistent Organic Pollutants) are banned for export;

- All dangerous chemicals exported to third countries have to be labelled and packaged in the same way as they must be within the Community.

- Consistency with the other policies and objectives of the Union

The proposal is fully in line with existing policies and objectives aimed at protecting human health and the environment globally such as those laid down in the 6th Environmental Action Programme.

3.

CONSULTATION OF INTERESTED PARTIES AND IMPACT ASSESSMENT


- Consultation of interested parties

4.

211 Consultation methods, main sectors targeted and the general background


Numerous parties have been consulted within the framework of the meetings of Designated National Authorities (DNAs) under Regulation (EC) No 304/2003, which have regularly reviewed issues relating to implementation. Participants have included stakeholders such as industry and NGOs as well as Member States, all of whom have had an opportunity to give their opinions and to make comments and been invited to make written submissions on particular issues.

In addition, Member States were able to comment on problems relating to implementation in their reports made pursuant to Article 21 of the Regulation.

5.

212 Summary of responses and how these have been taken into account


The responses confirmed the need for a limited number of technical amendments to improve the functioning of the Regulation without changing its objectives and core provisions. These have been taken into account in the drafting of this proposal.

- Collection and use of expertise

No recourse to external expertise has been necessary.

- Impact assessment

The current rules are generally working well. A new regulation with certain technical amendments is the only feasible option. Overall the impact of the proposed new regulation is expected to be limited. The main effects will be as follows:

- There will be more clarity and transparency and increased legal certainty;

- Control of exports by customs will be enhanced, without unduly impeding trade that complies with the rules;

- There will not be any additional administrative burdens for exporters and authorities. On the contrary, in certain respects the proposed amendments will lead to a reduction. On the other hand, the burden for the Commission would increase to some extent;

- The current high level of protection for human health and the environment will be maintained.

1.

LEGAL ELEMENTS OF THE PROPOSAL



- Summary of the proposed action

Subject to the required change of the legal basis, the proposed new Regulation would essentially maintain all the provisions of the current Regulation, including those that go beyond the requirements of the Convention. However, as confirmed in the Commission's report under Article 21, experience of the existing arrangements has shown that certain technical amendments are needed to improve the functioning of the Regulation. The main changes are as follows.

6.

Changes and clarifications as regards certain definitions (Article 3)


Exporter

Under the Regulation, the exporter is essentially defined as the legal person shown on the shipping documents as the person with a contract with the consignee and responsible for determining the sending of the chemical out of the EC customs territory. However there have been problems in applying this definition in the context of the export notification procedure, which requires the exporter to notify the DNA of the Member State in which he is established, since sometimes the exporter can be a trader not established in the Community who has obtained the chemicals from an EC chemical manufacturer or distributor. It is therefore proposed to adapt the definition to cover this situation.

7.

Preparation


Under the Regulation, ‘preparation’ is defined as meaning a mixture or a solution composed of two or more substances, if the preparation, as defined in Directive 1999/45/EC, is subject to compulsory labelling under Community legislation, on account of the presence of any of those substances. This rather broad definition is appropriate in the context of Article 16, which relates to all exported dangerous chemicals. However it has caused some questions about the scope of the obligations as regards other operative provisions, particularly those relating to export notification and explicit consent under Articles 7 and 13 respectively. It is therefore proposed to revise the definition and to make it clearer in those operative provisions that preparations are only subject to the requirements when they contain a chemical(s) listed in the relevant part(s) of Annex I of the Regulation to the extent that its presence is such that it could trigger labelling, irrespective of the presence of any other substances in the preparation.

Changes and clarifications to the so-called explicit consent procedure (Article 13.6)

In around half of the cases to date, despite the efforts made by the DNAs of the exporting Member States to obtain explicit consent, no response is forthcoming from the importing country, in some cases for many months or even years. As a result, exports cannot proceed, despite the fact that often the substances are not banned or severely restricted in the importing countries. The current system thus causes difficulties for exporters and exporting DNAs without necessarily affording greater protection to importing countries. The situation as regards chemicals listed in part 2 of Annex I (chemicals banned or severely restricted in the EC within a Convention use category and thus qualifying for PIC notification but that are not yet PIC chemicals) is particularly problematic.

Against this background, certain limited possibilities for exports to proceed on a temporary basis, while further efforts are made to obtain explicit consent, seem appropriate. It is proposed that, if, despite all reasonable efforts by the exporter’s DNA and the Commission, there is no response within 2 months, available documentary evidence from official sources that the chemical is registered, authorised or otherwise allowed for use in the importing country can be regarded as sufficient indication of consent for exports to proceed ad interim pending a response. This would be compatible with the so-called 'status quo' provisions of Article 11.2 of the Convention, but would be more restrictive. Moreover registration certificates etc are frequently specific to a given product and supplier so that the scope for exports to proceed would be limited accordingly. Furthermore, it is proposed that if there is no response after 3 months, exports can proceed for a maximum 12 months pending receipt of explicit consent to subsequent exports. It also proposed that where chemicals are being exported to OECD countries the requirement can be waived if certain conditions are fulfilled.

The rules as regards the period of validity of explicit consents obtained would also be clarified. The current provisions imply that consents obtained (unless otherwise qualified by the importing country) are potentially open-ended. However it is proposed that consents obtained, as well as cases where alternative evidence is accepted, should be periodically reviewed.

To further improve and strengthen the functioning of the system, it is also proposed that requests for consent and renewals should be channelled through the Commission (subject to the necessary resources being made available). This would help to prevent the unnecessary overlaps or duplication of effort that sometimes can occur. It may also help to avoid possible misunderstandings and confusion in importing countries, which currently receive export notifications from the Commission and requests for consent from the Member States.

8.

Changes to reinforce and strengthen customs control of exported chemicals while at the same time facilitating trade (Article 17)


In most Member States the customs authorities play a key role in ensuring compliance with the Regulation, in particular as regards controlling exports. In order to meet their specific needs in this regard, several actions are already in hand, as follows.

- classifying chemicals subject to Regulation 304/2003 within the Combined Nomenclature (CN) so that warning flags could be included in the Integrated Tariff of the European Communities (TARIC) against the relevant CN codes that would alert customs officers to the fact that the chemicals concerned are or could be subject to special rules.

- developing a version of the Commission's EDEXIM database (which includes data on export notifications made, explicit consents obtained etc) specifically for customs authorities. This would help them to check whether or not a particular export shipment can be allowed to proceed. To facilitate this, it is planned that there should be unique reference or code numbers generated by the system that would be quoted by exporters in their export declarations. Customs officers would be able if necessary to check these code numbers on EDEXIM to verify compliance. Linked to this initiative, work is also well advanced in providing in TARIC for such codes to be used by exporters in section 44 of the export declaration form (the Single Administrative Document).

Work on the above package of measures is expected to be completed in advance of adoption of the new Regulation. In order for such a system to be fully effective, it is proposed to make the use of the codes by exporters a requirement in the new Regulation. However there would be a short grace period of three months following entry into force to enable all concerned to become familiarised with the system.

All this would obviate the need for supporting documents to be submitted with export declarations, which would thus help customs control but also reduce the administrative burden on both customs and exporters, thereby facilitating trade.

- Legal basis

In line with the judgment of the Court, the proposed new Regulation is based on Article 133 (relating to the Common Commercial Policy) and Article 175 i (relating to Environmental Protection) of the Treaty.

- Subsidiarity principle

The proposal does not fall under the exclusive competence of the Community. It fully complies with the principle of subsidiarity since its objectives cannot be achieved by the Member States because a harmonised approach is needed to ensure that the Community, as a Party to the Convention, meets its international obligations.

- Proportionality principle

The proposal complies with the proportionality principle since it is based on experience gained within the existing system. It concentrates on changes only where they are deemed necessary and appropriate for its proper functioning.

The proposal aims to minimise the administrative burden without prejudicing the level of protection afforded to human health and the environment.

- Choice of instrument

Given that the existing legislation to be replaced is in the form of a Regulation, this is the most appropriate instrument.

2.

BUDGETARY IMPLICATION



The proposal has no implication for the Community budget, except the need for limited additional staff resources to deal with the work arising from the proposed changes to the Commission role in the explicit consent procedure. (see financial statement attached).

9.

ADDITIONAL INFORMATION


- Detailed explanation of the proposal

The proposed Regulation would replace the existing, but most of the provisions would be unchanged and the structure (including the numbering of the Articles) would be the same. The following summarises the main content of the proposed Regulation.

10.

Article 1


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

11.

Article 2


This outlines the scope of the Regulation. The exemptions are broadly in line with those provided for in the Convention, with certain clarifications, taking into account relevant Community legislation.

12.

Article 3


Article 3 sets out the definitions, including those taken from the definitions used in the Convention, adapted as necessary.

A number of definitions in the existing Regulation have been amended as follows:

- A revised definition for exporter has been introduced to address the enforcement problems referred to above.

- The definition of preparation has been revised and the scope of the rules of Articles 7, 9, 13 and 14 i in relation to preparations clarified.

- The definitions of' Chemical subject to the PIC procedure', Party to the Convention and Party have been adapted to take account of the entry into force of the Convention.

- The definitions of Convention, PIC procedure, the Conference of the Parties Chemical Review Committee, the Secretariat and Decision Guidance Document are not strictly necessary and are introduced when mentioned for the first time in the operative provisions.

13.

Article 4


The wording of this Article, relating to designated authorities, is in line with the Convention and is essentially unchanged.

14.

Article 5


This Article relates to the Community’s participation in the Convention, including the Commission's role as the common designated authority for the Community.

15.

Article 6


This Article defines the chemicals that are subject to export notification, qualify for PIC notification, and are subject to the international PIC procedure.

16.

Article 7


Article 7 sets out the export notification procedure. It applies to all exports of chemicals that are listed in Part 1 of Annex I to the proposed Regulation. The notification must provide the information laid down in Annex III. The Commission will have the central role in sending notifications to importing countries and there will continue to be a centralised register of notifications on the Commission’s EDEXIM database. The only substantive change is, as indicated above, the introduction of unique code numbers for export notifications that are verified as complete, of which exporters will be informed so that these can be quoted in their export declarations.

17.

Article 8


This Article outlines the procedure for handling export notifications from third countries..

18.

Article 9


Article 9 requires annual reporting on the quantities of Annex I chemicals traded.

19.

Article 10


This Article provides that where a chemical qualifies for PIC notification following final Community regulatory action, the Commission shall notify the Convention’s Secretariat, providing the information laid down in Annex II.

Member States may notify national regulatory actions compatible with Community law. Following a prior consultation procedure involving all other Member States, these can be submitted to the Convention secretariat via the Commission.

20.

Article 11


This Article provides that when a chemical is banned or severely restricted, but fails to qualify as a candidate for PIC notification under Article 10, the Commission will inform the PIC Secretariat of the relevant regulatory action under the Convention's information exchange provisions.

21.

Article 12


Article 12 deals with obligations in relation to imports of chemicals. It lays down the procedure for handling decision guidance documents for PIC chemicals; and taking Community import decisions for the chemicals concerned.

22.

Article 13


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

The first relates mainly to procedures for PIC chemicals (listed in Part 3 of Annex I to the Regulation) and ensuring that the import decisions of importing parties are respected. The basic principle, which goes much further than the Convention, is that such chemicals should not be exported without the explicit consent of the importing country. The same approach is applied to any chemical that is banned or severely restricted within the Community and qualifies for PIC notification but is not a PIC chemical.

For the reasons explained in section 3 above, it is proposed that under certain conditions in cases where the importing country fails to respond, exports may proceed on a limited basis ad interim pending a response. It is also proposed that under certain conditions the requirement can be waived for exports to OECD countries. In addition, it is proposed that the validity of consents obtained and waivers granted should be regularly reviewed. Explicit consent must be sought and received via the DNA in the exporting Member State. However, for the reasons already explained in section 3, it is proposed, subject to the necessary resources being made available, that all requests, including requests for renewals, should be routed through the Commission, which will post the information on EDEXIM.

The second element comprises obligations of a more general nature. For example certain minimum standards are imposed as regards the useful life of exported chemicals, the purity specifications of pesticides and their packaging, storage and stability in order to minimise risks under conditions of use in developing countries.

23.

Article 14


Article 14 extends the export notification procedure laid down in Article 7 to certain articles. It also provides for certain chemicals and articles, the use of which is prohibited in the Community, not to be exported. These chemicals and articles are listed in Annex V.

24.

Article 15


This Article deals with the question of information on transit movements for PIC chemicals. The details of the importing Parties requiring information, and what type of information, will be set out, as they become available, in Annex VI.

25.

Article 16


Article 16 lays down the rules applicable to information to accompany exported chemicals. Without prejudice to the requirements of the importing country, and taking into account relevant international standards, all dangerous chemicals for export should be subject to packaging and labelling and be accompanied by a safety data sheet in accordance with relevant Community legislation. As far as possible the information should be in the principal language(s) of the importing country.

26.

Article 17


Article 17 refers to the role of the Customs Services of the Member States under the proposed Regulation.

It is proposed to strengthen and facilitate control by introducing a requirement that exporters must include special code numbers in their export declarations corresponding to the export notifications they have made and the explicit consents or waivers obtained. Corresponding provisions are included in Articles 7 and 13 providing for such code numbers to be made available to exporters for such use.

27.

Article 18


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

28.

Article 19


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

29.

Article 20


This Article concerns technical assistance to developing countries and countries with economies in transition.

30.

Article 21


Article 21 deals with monitoring and reporting within the Community on the operation of the proposed Regulation.

31.

Article 22


Article 22 sets out the procedures to be followed for updating all annexes. In the light of the recent changes to the procedures for the exercise of implementing powers conferred on the Commission i , the current regulatory procedure for additions to Annex I has been changed to a regulatory procedure with scrutiny. It is proposed that inclusion of POPs chemicals in Annex V should be subject to the same procedure.

32.

Article 23


This Article provides that technical guidance documents will be drawn up to help in implementation. There have been similar documents under the existing Regulation. The documents to be developed will include guidance for the authorities involved in controlling exports and imports such as customs authorities.

33.

Article 24


This Article outlines the committee procedures to be followed, using the committee established by Article 29 of Council Directive 67/548/EEC. These provisions also have been adapted in line with the revised procedures for the exercise of implementing powers conferred on the Commission referred to above.

34.

Articles 25 and 26


These two Articles relate respectively to references to Regulation (EC) No 304/2003 in other legislation; and entry into force of the proposed new Regulation. A short transitional period of 3 months is foreseen before entry into force of the Article 17 provisions relating to the mandatory use of code numbers in export declarations.

35.

Annexes


Annex I to the Regulation lists the chemicals subject to the different procedures and is based on that contained in Regulation (EC) No 304/2003 as amended by Commission Regulations 1213/2003, 775/2004 and 777/2006.

Annex II sets out the information that must be submitted by when the Commission notifies final Community regulatory action pursuant to Article 10.

Annex III lists the information that by an exporter must submit in an export notification pursuant to Article 7. Certain clarifications have been introduced.

36.

Annex IV sets out the information to be provided pursuant to Article 9 about trade in chemicals listed in Annex I. The scope of the quantities to be reported has been clarified


Annex V lists the chemicals and articles that shall not be exported in accordance with Article 14 i.

Annex VI lists parties requiring information on transit movement of PIC chemicals (Article 15 refers).