Explanatory Memorandum to COM(2007)611 - Amendment of Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC in order to adapt them to Regulation (EC) … on Classification, Labelling and Packaging of Substances and Mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 [SEC(2007) 1334] [SEC(2007) 1335] - Main contents
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| dossier | COM(2007)611 - Amendment of Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC in ... |
|---|---|
| source | COM(2007)611  |
| date | 16-10-2007 |
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 (...)5
Legal elements of the proposal (...)5
Legal basis (...)5
Subsidiarity and proportionality (...)5
Subsidiarity (...)5
Proportionality (...)6
Choice of legal instrument (...)6
Introduction to the proposal (...)6
DECISION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Council Directives 76/768/EEC, 88/378/EEC, 1999/13/EC and Directives 2000/53/EC, 2002/96/EC and 2004/42/EC in order to adapt them to Regulation (EC) … on Classification, Labelling and Packaging of Substances and Mixtures, and amending Directive 67/548/EEC and Regulation (EC) No 1907/2006 (...)8
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, hereinafter 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 Decision aims to make such changes to a number of downstream acts, 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 Regulation aiming to make changes in order to address the effects of the proposal on classification, labelling and packaging for an existing Regulation.
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 Decision proposes such changes to the provisions of Directives 76/768/EEC, 88/378/EEC, 1999/13/EC, 2000/53/EC, 2002/96/EC and 2004/42/EC.
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. However, the assessment of the effects on national legislation is within the competence of Member States. The Commission would encourage Member States to analyse national downstream acts along the lines of the study on EU legislation.
Public stakeholder consultation
Internet consultation
The Commission launched a public stakeholder consultation on the proposal for a 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 proposal for a Regulation on classification, labelling and packaging of substances and mixtures for all downstream acts covered by the current proposed Decision. For Directives 76/768/EEC, 88/378/EEC, 2000/53/EC and 2002/96/EC, potential effects are minimised by covering, in the reference to dangerous substances and mixtures according to the proposed Regulation on classification, labelling and packaging of substances and mixtures, those endpoints which are already referred to under the current EU regime on classification and labelling, while not adding further endpoints.
As to Directive 1999/13/EC, no further adaptation of reference to the classification criteria is made because potential effects are deemed irrelevant for the scope of the Directive. Directive 2004/42/EC does not base any additional obligation on the classification of substances and mixtures.
For each of the EU downstream Directives which are proposed for amendment by the current proposed Decision, 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.
Contents
- Legal elements of the proposal
- Background to the proposal (...)3
- 1. Reasons and Objectives (...)6
- 2. Detailed provisions (...)7
- LEGISLATIVE FINANCIAL STATEMENT (...)15
- 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
- Subsidiarity and proportionality
- Proportionality
- Choice of legal instrument
- Introduction to the proposal
- 1. Reasons and Objectives
- 2. Detailed provisions
This proposal has a double legal basis consisting of both Article 95 and Article 175 i of the EC Treaty. This double legal basis is the appropriate legal basis for this proposed Decision because it minimises the effects for six existing Directives which would result from the proposal for a Regulation on classification, labelling and packaging of substances and mixtures. Three of those Directives are based on Article 175 i of the EC Treaty, three of them are based on Article 95 of the EC Treaty. Both legal bases rely on the co-decision procedure laid down in Article 251 of the EC Treaty and they are therefore compatible from a procedural viewpoint. A double legal basis comprising both aforementioned Articles was recently used by the European Parliament and the Council for the Regulation on certain fluorinated greenhouse gases i.
Subsidiarity
Six existing Directives in the fields of cosmetic products, safety of toys, emissions of volatile organic compounds, end-of-life vehicles and waste electric and electronic equipment already contain substantive legal provisions. The proposed Decision will amend the existing Directives to adapt them 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 are contained in the proposal for a Regulation on classification, labelling and packaging of substances and mixtures. In that proposal, some hazard classes and categories are added in comparison to the current EU system, leading to classification of substances and mixtures which previously were not classified. To ensure proportionality, there should be no change in the scope of downstream legislation, so as not to trigger new obligations. The proposed Decision aims to ensure this, by including in six Directives a reference to the concept of “dangerous” which is found in Article 3 i of the proposal for a Regulation on classification and labelling of substances and mixtures and which is in line with the current EU system.
Therefore this proposal for a Decision is proportionate.
The choice of a Decision is justified. On the one hand, this proposal amends six existing Directives which have been transposed into Member State legislation and whose legal nature is not affected by the proposal for a Regulation on classification, labelling and packaging of substances and mixtures. The amendments introduced by this Decision in turn will have to be transposed in Member State legislation. It is therefore appropriate to choose an instrument that is not directly applicable, but that is addressed to the Member States instead. On the other hand, the majority of the amendments contained in this proposal are only intended to become applicable several years from the adoption of the amending act, namely from 1 December 2010 and from 1 June 2015 respectively. This would either require different transposition dates to be set for the different provisions depending on the relevant dates, which is unorthodox wording for a Directive from a legal perspective, or a single date of transposition, which would require Member States to adopt national legislation with a deferred applicability for some provisions, which is unusual for a Directive. A Decision is more efficient in laying down clearly the obligations of Member States in this regard and is therefore to be preferred.
This Decision amends six existing Directives to adapt them to the criteria for the classification and labelling of substances and mixtures laid down in the proposal for a Regulation on classification, labelling and packaging of substances and mixtures.
The main objective of this Decision is to address the effects of the introduction of new classification criteria for substances and mixtures for six Directives which refer to classification of substances or mixtures, so as to prevent undesired changes in scope and obligations. Where necessary, it adapts the provisions of those Directives to the new terminology resulting from the new criteria and the new hazard statements introduced by the proposal on classification, labelling and packaging. The term “mixture” is introduced to replace the term “preparation”, in line with the proposal on classification, labelling and packaging of substances and mixtures.
Where the Directives refer in general to the test methods laid down in Directive 67/548/EEC, this proposal updates this reference in line with the recently adopted Regulation 1907/2006 (Reach) which foresees a Commission Regulation containing these methods.
For Directive 1999/13/EC, this proposal contains a change which is consequential to the replacement of the former risk phrase R40 by two new risk phrases called R40 and R68, operated by Directive 2001/59/EC. This replacement had until now not been reflected in the wording of Directive 1999/13/EEC. It is appropriate to make this change now to ensure a correct transition to the corresponding hazard phrases foreseen in the proposal on classification, labelling and packaging of substances and mixtures.
Articles 1 to 6 introduce the required changes to Directives 76/768/EEC, 88/378/EEC, 1999/13/EC, 2000/53/EC, 2002/96/EC and 2004/42/EC 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 under the previous section.
The staggered dates of entry into effect of the changes reflect the phased entry into effect of the aforementioned proposal for a Regulation. This is logical, as the Decision introduces changes which are consequential to the adoption of that Regulation.
Article 7 is a standard article which is required due to the legal nature of a Decision.