Explanatory Memorandum to COM(2013)102 - Adaptation of five directives to Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures - Main contents
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| dossier | COM(2013)102 - Adaptation of five directives to Regulation 1272/2008 on classification, labelling and packaging of substances and mixtures. |
|---|---|
| source | COM(2013)102  |
| date | 26-02-2013 |
Article 153(1)(a) of the Treaty on the Functioning of the European Union (hereinafter TFEU) stipulates that ‘the Union shall support and complement the activities of the Member States in improvement of the working environment to protect workers’ health and safety’. Under Article 153(2) of the TFEU, the Commission may propose directives which lay down minimum requirements for gradual implementation, having regard to the conditions and technical rules obtaining in each of the Member States.
On the basis of these legal provisions, an appropriate occupational safety and health framework has been adopted with a view to protecting workers’ health and safety from risks due to exposure to chemicals at the workplace. Following the adoption of Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging (CLP) of substances and mixtures i, in order to implement, within the European Union, the United Nations Globally Harmonised System of Classification and Labelling of Chemicals (hereinafter GHS)[2], certain aspects of this legal framework need to be adapted.
Directives 92/58/EEC[3], 92/85/EEC i, 94/33/EC[5], 98/24/EC[6] and 2004/37/EC[7] contain references to EU chemical classification and labelling legislation. If these Directives are to remain effective, they need to be aligned to the new legislation in this area. Thus, the aim of the present Directive is to update references and terminology of the five aforesaid Directives to bring them into line with the applicable EU chemical classification and labelling legislation. In doing so, no changes to the scope or level of protection provided by these Directives are required.
The GHS is a United Nations system for identifying hazardous chemicals and informing users about the related hazards by means of standard symbols and phrases on packaging labels, and safety data sheets.
Following successful negotiations on the Commission’s proposal, the European Parliament and the Council adopted the CLP Regulation on 16 December 2008. This Regulation aligns the existing EU legislation to the GHS and was published in the Official Journal on 31 December 2008.
The CLP Regulation entered into force on 20 January 2009. The deadlines for classification in accordance with the new rules are 1 December 2010 for substances and 1 June 2015 for mixtures. The CLP Regulation will ultimately replace the current rules on classification, labelling and packaging of substances (Directive 67/548/EEC) and preparations (Directive 1999/45/EC) after the transitional period provided for in its Article 61.
The CLP Regulation is expected to facilitate global trade and harmonised communication of information on hazards posed by chemicals and to promote regulatory efficiency. It will complement the ‘REACH Regulation’[8].
Implementation of the GHS in the European Union via the CLP Regulation will require companies to classify, label and package their substances and mixtures appropriately before placing them on the market after a transitional period during which the two systems, CLP Regulation and the combination of the substances and preparations directives, will apply side by side. The aim is to protect workers, consumers and the environment by means of labelling and indicating any potential hazardous effects of chemicals.
The safety data sheets provided by suppliers of chemicals are a major source of information for employers and workers. Transitional arrangements will also apply to the legislative requirements governing safety data sheets which are now regulated in Article 31 of the REACH Regulation.
The aforementioned five Directives need to be amended in order to update the references to the EU chemical classification and labelling legislation described above, without any changes to the scope or level of protection provided by these Directives.
This proposal relates to the key action on quality of work and working conditions identified in the Flagship initiative ‘An agenda for new skills and jobs[9]’
It is consistent with the objectives of other policies of the European Union, in particular those aiming at improvement of the regulatory framework in order to develop a clear, understandable, up-to-date and user-friendly body of secondary EU legislation, in the interests of citizens and economic operators.
Consultation of interested parties
- Consultation of the Advisory Committee on Safety and Health at Work (ACSHW), in accordance with the Council Decision of 22 July 2003 setting up that Committee[10]. The Committee adopted its opinion on 1 December 2011.
- Consultation of the social partners in accordance with Article 154(2) and (3) of the TFEU. The first-stage consultation (Article 154(2) of the TFEU) took place between 9 December 2009 and 26 March 2010. The second-stage consultation (Article 154(3) of the TFEU) took place between 17 January and 17 March 2011.
The results can be summarised as follows:
· Five out of six social partners which responded agree with the content of the envisaged regulatory initiative.
· The majority of the respondents agree with the approach of a single amending Directive. One of the workers’ representatives suggested that the required amendments should be done separately and not by means of a single amending Directive, as two of the five Directives in question are currently under review for other reasons.
· An approach that includes maintaining a formal link to the EU chemical classification system (the CLP Regulation) is commonly preferred.
· The social partners are in favour of additional non-binding measures that can help employers and workers to understand occupational safety and health issues arising from the new requirements for chemical classification, labelling and packaging. Explanatory guidance, in particular for SMEs, would be considered useful. The Commission, in cooperation with the ACSHW, has prepared guidance material which will be published in the near future.
· None of the social partners wished to initiate a dialogue on the matter.
The proposed amendments to the five aforesaid Directives maintain the current level of worker protection with no additional requirements being introduced. Thus, the proposed changes do not create any significant impact that would require a formal impact assessment to be carried out.
A full impact assessment for the primary piece of legislation, the European Parliament and Council Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures, was presented during 2007[11].
Contents
- Legal elements of the proposal
- Budgetary implications
- Grounds for and objectives of the proposal
- General context
- Consistency with other European Union policies and objectives
- 2. Consultation of interested parties and impact assessment
- Impact assessment
- Summary of the proposed measures
- Legal basis
- Subsidiarity principle
- Proportionality principle
- Choice of instrument
- 5. Additional information
- Repeal of existing legislation
- European Economic Area
- Detailed explanation of the proposal by article
The proposal amends the relevant articles and annexes of Directives 92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC and 2004/37/EC, in order to achieve the objectives mentioned under point 1 above.
Article 153(2) of the TFEU.
The subsidiarity principle applies in so far as the proposal concerns a field – protection of the health and safety of workers at work – which does not fall under the exclusive competence of the European Union.
The objectives of the proposal cannot be achieved sufficiently by the Member States themselves, as the provisions of Directives cannot be amended or repealed at national level.
The objectives of the proposal can be achieved only by Union action, entailing amendment of an act of EU law that is currently in force, which cannot be done by the Member States themselves.
The principle of subsidiarity is respected in as much as the proposal amends existing Union legislation.
The proposal complies with the proportionality principle. The minimum EU action necessary to ensure the continued effectiveness of existing policy will be taken, without introducing any additional requirements.
Proposed instrument: Directive.
No other instrument would have been suitable. The aim is to amend five EU Directives and the only way to do this is to adopt another Directive.
The proposal has no implications for the Union budget.
Simplification
The proposal contributes to the simplification of the legislative framework by introducing appropriate proportionality and flexibility.
Not applicable. This proposal contains only amendments to existing Directives.
This draft instrument is concerned with a subject covered by the EEA Agreement and must therefore extend to the European Economic Area.
Articles 1 to 5 introduce the required changes to the relevant provisions of Directives 92/58/EEC, 92/85/EEC, 94/33/EC, 98/24/EC and 2004/37/EC, in order to align them to the references to the European Parliament and Council Regulation (EC) No 1272/2008 on classification, labelling and packaging of substances and mixtures.
Regarding the non-exhaustive list of agents mentioned in the Annex, Part I, Section 3 of Directive 94/33/EC, an exact correlation between the pre-existing and new chemical classification systems cannot be achieved. The proposal therefore presents an alignment that may result in a limited number of additional substances coming within the scope of the Annex. However, the proposed changes are designed to maintain the policy objective of Article 7 of this Directive, which remains unchanged.
Articles 6 and 7 concern the transposition, entry into force and application of the Directive.
Article 8 is a standard article reflecting the legal nature of a Directive.