Explanatory Memorandum to COM(2011)245 - Export and import of dangerous chemicals(recast) - Main contents
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This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2011)245 - Export and import of dangerous chemicals(recast). |
|---|---|
| source | COM(2011)245  |
| date | 05-05-2011 |
Regulation (EC) No 689/2008 of the European Parliament and of the Council of 17 June 2008 concerning the export and import of dangerous chemicals ('the Regulation') implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade.
The following reasons lead to the proposal to recast Regulation (EC) No 689/2008:
– The Regulation includes references to Council Directive 67/548/EEC of 27 June 1967 on the approximation of the laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances 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relating to the classification, packaging and labelling of dangerous preparations, which are or will be replaced and repealed by Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and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) 1907/2006. It is, therefore, necessary to align the Regulation with Regulation (EC) No 1272/2008.
– In order to support the Commission in its tasks as a common designated authority foreseen under the Regulation, it is proposed to involve the European Chemicals Agency ("the Agency") in certain administrative, technical and scientific tasks necessary for the implementation of the Regulation.
– In the light of Regulation (EC) No 1272/2008 and of the experience of the functioning of the procedures under Regulation (EC) No 689/2008, it is appropriate to include certain technical amendments to the operative provisions such as clarify the definitions of a substance, a mixture and an article, and request the use of the reference identification number for exports that are not subject to export notification.
– In the light of the experience gained with the implementation of the explicit consent procedure provided for by Regulation (EC) No 689/2008 it is appropriate to provide for additional conditions that may allow exports to proceed in the absence of a reply from the importing country whilst not lowering the protection afforded to importing countries.
– In view of the changes introduced by the Lisbon Treaty, it is necessary to clarify provisions relating to the external representation of the European Union and to adapt the provisions concerning comitology. In particular, it should be specified which rules are subject to implementing acts and clarified which conditions apply to the adoption of delegated acts.
The Rotterdam Convention was adopted in September 1998. It entered into force on 24 February 2004. The aim of the Rotterdam Convention 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. This is done by facilitating information exchange about their characteristics, by providing for a national decision-making process on their import and export and by disseminating these decisions to Parties.
Regulation (EC) No 689/2008 implements the Rotterdam Convention on the Prior Informed Consent (PIC) Procedure for certain hazardous chemicals and pesticides in international trade. The provisions of the Regulation go beyond those of the Convention and offer more protection to importing countries since they are addressed to all countries and not just Parties to the Convention. The scope of the Regulation is not limited to chemicals that are banned or severely restricted under the Convention but also covers chemicals that are banned or severely restricted at EU level. In addition the Regulation ensures that all chemicals are appropriately packed and labelled when exported.
As noted above, the current Union rules relating to the export and import of dangerous chemicals are laid down in Regulation (EC) No 689/2008, as most recently amended by Commission Regulation (EU) No 196/2010.
The Regulation goes significantly beyond the requirements of the Convention. The key differences can be summarised as follows:
1. The rules apply to exports to all countries, whether or not they are Parties to the Convention;
2. The Regulation stipulates the obligation of an annual export notification for a wider range of chemicals. For the purposes of determining which chemicals should be subject to the procedure, the two use categories (pesticides and industrial chemicals) foreseen by the Convention 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 containing such chemicals are also covered;
3. PIC chemicals and chemicals that are banned or severely restricted in the Union in a Convention use category cannot be exported without the explicit consent of importing countries;
4. Certain articles and chemicals (such as those chemicals that are also subject to the Stockholm Convention on Persistent Organic Pollutants) are banned for export;
5. All dangerous chemicals exported to third countries have to be labelled and packaged in the same way as they must be within the Union unless third countries require otherwise.
The proposal is fully in line with existing policies and objectives aimed at protecting human health and the environment globally.
2. RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENT 2.1. Consultation of interested parties
Consultation methods, main sectors targeted and the general background
Due to the nature of the recast, which introduces only minor technical amendments to the operative provisions, it was not deemed necessary to carry out a formal consultation of stakeholders.
Relevant stakeholders have been informed within the framework of the meetings of Designated National Authorities (DNAs) under Regulation (EC) No 689/2008 about the intended modifications. 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.
All Member States and other stakeholders participating in the meetings of Designated National Authorities (DNAs) under Regulation (EC) No 689/2008 supported the intended changes including the transfer of tasks to the Agency.
As no substantive changes are proposed in the context of this review, it was not deemed necessary to make use of external expertise.
The current rules set out in the Regulation are generally working well and only minor technical modifications are necessary to facilitate the implementation. The main changes aim to align the Regulation to the Lisbon Treaty and general chemicals legislation as well as to involve the Agency in the tasks foreseen under the Regulation. As the overall impact of the review is expected to be limited, it was not considered imperative to carry out an impact assessment. The main effects of the changes can be summarised as follows:
– As a result of the proposed changes, there will be more clarity, transparency and increased legal certainty for all parties involved in the implementation of the Regulation;
– The proposal will not add any additional administrative burden for exporters or the competent authorities involved in the implementation of the Regulation. On the contrary, with respect to exports that are exempted from export notification the proposed amendments will lead to a reduction of administrative burdens;
– Some tasks will be transferred from the Commission to the European Chemicals Agency, which is expected to reduce the overall costs and to increase the scientific knowledge available for implementation;
– The current high level of protection of human health and the environment will be maintained.
The proposed new Regulation would essentially maintain all provisions of the current Regulation, including those that go beyond the requirements of the Convention. However, certain technical amendments are deemed necessary to improve the clarity and functioning of the Regulation. The main changes are as follows:
– Changes and clarifications as regards certain definitions (Article 3)
Definitions are amended in order to align this Regulation with Regulation (EC) No 1272/2008. The term ‘preparation’ has been replaced by ‘mixture’ to reflect the changes in the general chemicals legislation and a definition for ‘substance’ is added.
– Changes to the so-called explicit consent procedure (Article 14(7))
In around 30% of the cases to date, despite the efforts made by the DNAs of the exporting Member States and the Commission 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 the substances are often not banned or severely restricted in the importing countries. The current system thus causes difficulties for exporters and the DNAs of exporting Member States 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 Union within a Convention use category and thus qualifying for PIC notification but that are not yet PIC chemicals) is particularly problematic because authorities in importing countries are not always aware of EU procedures or do not always have the mandate or the means to respond.
Against this background, certain limited possibilities for exports to proceed on a temporary basis, while further efforts are being made to obtain explicit consent, seem appropriate. It is proposed to allow the export to proceed if there is documentary evidence from official sources showing that the chemical has been imported or used in the last 5 years and no regulatory action has been taken, if, despite all reasonable efforts by the exporter’s DNA, the Agency and the Commission, there is no response from the importing country within 2 months. The evidence showing that the chemical is imported in the country can be regarded as sufficient indication of consent for exports to proceed ad interim for a period of 12 months pending a response. This would be compatible with the so-called 'status quo' provisions of Article 11 of the Convention, but would be more restrictive. Moreover import licenses are frequently specific to a given product or supplier or importer so that the possibility for exports to proceed would be limited accordingly.
– Involvement of the European Chemicals Agency (Articles 6 and 24)
The involvement of the Agency in the implementation of this Regulation is because of its expertise and experience with the implementation of the general chemicals legislation and international agreements on chemicals considered particularly desirable, in particular regarding the management of the European Database on Export and Import of dangerous chemicals and some related administrative tasks.
– Adaptation of provisions related to the external representation of the Union and of the comitology procedures to the Lisbon Treaty (Articles 5 and 26 to 29)
The provisions related to the external representation of the Union have been aligned with the Lisbon Treaty. The provisions in which certain powers are conferred upon the European Commission have also been revised in order to reflect the entry into force of the Lisbon Treaty.
In line with the judgment of the Court in case C-178/03 (Commission v Parliament and Council), the proposed Regulation will be based on Article 192 (relating to Environmental Protection) of the Treaty on the functioning of the European Union and Article 207 (relating to the Common Commercial Policy).
The subsidiarity principle applies insofar as the proposal does not fall under the exclusive competence of the European Union. The proposal 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 Union, as a Party to the Convention, meets its international obligations.
The proposal complies with the proportionality principle since it does not go beyond what is necessary to achieve its objectives. It concentrates on changes only where they are deemed necessary and appropriate for its proper functioning or where they are necessary due to changes in other legislation.
Furthermore, the proposal aims to reduce the administrative burden without compromising the level of protection afforded to human health and the environment.
Given that the existing legislation to be replaced is in the form of a regulation, this is the most appropriate instrument.
Contents
- BUDGETARY IMPLICATION
- 1.2. General context
- 1.3. Existing provisions in the area of the proposal
- 1.4. Consistency with the other policies and objectives of the Union
- 2. RESULTS OF CONSULTATIONS WITH THE INTERESTED PARTIES AND IMPACT ASSESSMENT 2.1. Consultation of interested parties
- Summary of responses and how these have been taken into account
- 2.2. Collection and use of expertise
- 2.3. Impact assessment
- 3. LEGAL ELEMENTS OF THE PROPOSAL 3.1. Summary of the proposed action
- 3.2. Legal basis
- 3.3. Subsidiarity principle
- 3.4. Proportionality principle
- 3.5. Choice of instrument
- 5. OPTIONAL ELEMENTS 5.1. Review/revision/sunset clause
- 5.2. Recasting
- ê 689/2008 (adapted)
The proposal is not expected to have important budgetary implications since no new tasks were introduced compared to Regulation (EC) 689/2008. The transfer of certain tasks from the Commission to the European Chemicals Agency is expected to reduce the overall costs of implementation. Further reductions may be achieved in a long-term perspective considering the potential for synergies with other tasks of the Agency.
The financing of the tasks carried out by the European Chemicals Agency will be provided in form of a subsidy from the Union budget.
The proposal includes a review clause, which is limited to the possibility to charge fees for services provided by the Agency. However, the Commission is obliged to regularly report on the implementation of the Regulation to the European Parliament and the Council.
The proposal involves recasting.
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