Explanatory Memorandum to COM(2007)613 - Amendment of Regulation (EC) No 648/2004 in order to adapt it to Regulation (EC) No … on Classification, Labelling and Packaging of Substances and Mixtures - Main contents
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| dossier | COM(2007)613 - Amendment of Regulation (EC) No 648/2004 in order to adapt it to Regulation (EC) No … on Classification, Labelling and ... |
|---|---|
| source | COM(2007)613  |
| date | 17-10-2007 |
Reasons and objectives 3
Coherence with other policies 3
Results of public consultations and impact assessments 4
Public stakeholder consultation 4
Internet consultation 4
Issues raised and how they are addressed 4
Impact assessments 4
Collection and use of expertise 4
Contents
- Legal elements of the proposal
- Legal elements of the proposal
- Background to the proposal 3
- Legal basis 5
- 1. Reasons and Objectives 6
- 2. Detailed provisions 6
- LEGISLATIVE FINANCIAL STATEMENT 10
- Coherence with other policies
- RESULTS OF PUBLIC CONSULTATIONS AND IMPACT ASSESSMENTS
- Issues raised and how they are addressed
- Impact assessments
- Collection and use of expertise
- Legal basis
- S ubsidiarity and proportionality
- Proportionality
- Choice of legal instrument
- INTRODUCTION TO THE PROPOSAL
- 1. REASONS AND OBJECTIVES
- 2. DETAILED PROVISIONS
Subsidiarity and proportionality 5
Subsidiarity 5
Proportionality 5
Choice of legal instrument 5
Introduction to the proposal 6
REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EC) No 648/2004 in order to adapt it to Regulation (EC) No … on Classification, Labelling and Packaging of Substances and Mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 7
EXPLANATORY MEMORANDUM
BACKGROUND TO THE PROPOSAL
REASONS AND OBJECTIVES
This proposal accompanies the Commission proposal for a Regulation of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures i. The latter proposal builds on existing chemicals legislation and establishes a new system on classification, labelling and packaging of hazardous substances and mixtures by implementing in the EU the international criteria agreed by the United Nations Economic and Social Council (UN ECOSOC) for the classification and labelling of hazardous substances and mixtures, called the Globally Harmonised System of Classification and Labelling of Chemicals (GHS).
Classification of substances and preparations under the currently applicable Directives 67/548/EEC and 1999/45/EC triggers other obligations in EU legislation, referred to as downstream legislation.
The Commission services have assessed the potential effects of the implementation of the GHS criteria on downstream legislation. Their analysis concludes that effects are either minimal or can be minimised by appropriate changes to particular downstream acts. This proposed Regulation aims to make such changes to such a downstream act, through amendments which take account of the effects of the proposal on classification, labelling and packaging of substances and mixtures. It is presented together with a proposed Decision aiming to make changes in order to address the effects of the proposal on classification, labelling and packaging for six existing Directives.
The analysis of the potential effects of the implementation of the GHS criteria on downstream legislation concluded that effects are either minimal or can be minimised by appropriate changes to particular downstream acts. This draft Regulation proposes such changes to the provisions of Regulation (EC) No 648/2004.
A proposal for a Regulation concerning the placing on the market of plant protection products is currently under discussion in the European Parliament and the Council. Once this proposal is adopted, the present proposal for a Regulation on amending EU downstream legislation should be revised in order to include also the Plant Protection Products Regulation, or a separate amending proposal should be presented, if appropriate.
During the stakeholder consultation which was held on the proposal for a Regulation on classification, labelling and packaging of substances and mixtures and which also addressed potential effects on downstream legislation, some parties mentioned the lack of analysis of national legislation referring to the EU classification criteria. To the extent this proposal addresses an existing Regulation, it does not require transposition at Member State level.
Public stakeholder consultation
Internet consultation
The Commission launched a public stakeholder consultation on the proposal for Regulation on classification, labelling and packaging of substances and mixtures on the internet from 21 August to 21 October 2006. All responses were published on the Internet. Some 370 contributions were received. 82% were sent by industry - companies or associations; of the 254 company responses, 45% came from enterprises with less than 250 employees. 10 NGOs responded. One trade union responded.
18 Member State governments and/or public authorities sent comments. Non-EU public authorities (Iceland, Norway, Switzerland, Romania) gave input as well. No international organisation sent comments. 97% of the responses support the implementation of the GHS in the EU. Overall the draft proposals of the Commission services were well appreciated by Member State authorities and industry.
Scope: A majority of respondents (59%) supported neither extending nor lowering the level of protection in comparison with the current EU system, except where necessary to ensure consistency with transport legislation or with the GHS. 5% had no opinion, including most of the NGOs. 36% favoured a different approach. Of these, one group (governmental bodies in Denmark, Sweden, Norway, Iceland), wanted to go beyond the scope of the current system; the second group (associations and companies ) proposed to include all GHS categories, but not to include the 'EU left-overs' which are not yet part of the GHS.
The Commission’s overall impact assessment for the proposed Regulation on classification, labelling and packaging of substances and mixtures and its consequential changes to related downstream legislation made use of the consultant reports prepared by RPA and London Economics as well as the responses to the stakeholder consultation. Specifically, the responses from companies on the costs have led to further efforts to quantify significant cost items. The overall analysis demonstrates that the implementation costs need to be kept in check so as to arrive at the net benefits of the GHS in the foreseeable future.
The measures set out in this proposal provide for an adaptation of the references to the classification rules and terminology according to the proposed Regulation on classification, labelling and packaging of substances and mixtures. Regulation (EC) 648/2004 does not base any additional obligation on the classification of substances and mixtures. There is therefore no need for further analysis beyond that set out in the overall impact assessment referred to above.
The GHS was developed by international organisations, with participation of a variety of stakeholders. Similarly, in the EU there have been continuous technical discussions with Member States and other stakeholders over the past years. Following the publication of the White Paper “Strategy for a future Chemicals Policy”, the Commission consulted widely with experts. The results of the technical working group on classification and labelling convened by the Commission in preparation for REACH i have been taken into account in drafting this proposal . Further studies were carried out i and an informal stakeholder discussion on the implementation of the GHS in the EU took place on 18 November 2005.
This proposal is based on Article 95 of the EC Treaty. This legal basis is appropriate for this proposed Regulation because it adapts an existing Regulation, which is itself based on Article 95 of the EC Treaty, to the proposed Regulation on classification, labelling and packaging of substances and mixtures.
Subsidiarity
An existing Regulation in the field of detergents already contains substantive legal provisions. The proposed Regulation will amend the existing Regulation to adapt it to the classification rules set forth in the proposal for a Regulation on classification, labelling and packaging of substances and mixtures. Those amendments need to be exactly the same in all Member States, and should therefore be regulated at Community level.
The criteria for the classification of substances and mixtures as hazardous and the rules on the labelling and packaging of hazardous substances and mixtures are contained in the proposal for a Regulation on classification, labelling and packaging of substances and mixtures. To ensure legal certainty and clarity of the obligations of the operators concerned, the provisions of Regulation (EC) 648/2004 should be amended to reflect the new situation. This is especially important as Regulations are directly applicable in the Member States and operators should be in no doubt as to the obligations which apply to them.
In ensuring this, this proposal for a Regulation is proportionate.
The choice of a Regulation is justified, as it amends an existing Regulation.
THIS PROPOSED REGULATION AMENDS AN EXISTING REGULATION TO THE PROVISIONS OF THE PROPOSAL FOR A REGULATION ON CLASSIFICATION, LABELLING AND PACKAGING OF SUBSTANCES AND MIXTURES WHICH WILL REPEAL AND REPLACE DIRECTIVES 67/548/EEC AND 1999/45/EC.
The objective of this Regulation is to reflect the introduction of a new Regulation on classification, labelling and packaging of substances and mixtures and of new terminology for a Regulation which refers to classification of substances or mixtures. The term “mixture” is introduced to replace the term “preparation”, in line with the proposal on classification and labelling of substances and mixtures.
Article 1 introduces the required changes to Regulation (EC) No 648/2004 in line with the findings of the analysis of the potential effects of the proposal for a Regulation on classification, labelling and packaging of substances and mixtures on EU downstream legislation and the objectives discussed in the previous section. As far as Regulation (EC) No 648/2004 makes general references to Directives 67/548/EEC and 1999/45/EC, which will be repealed by the Regulation on classification, labelling and packaging of substances and mixtures, it needs to be updated so as to refer to that Regulation.
The staggered dates of entry into effect of the changes reflect the phased entry into effect of the aforementioned proposal for a Regulation.