Annexes to COM(2011)763 - Alignment of ten technical harmonisation directive 768/2008/EC on a common framework for the marketing of products - Main contents
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| dossier | COM(2011)763 - Alignment of ten technical harmonisation directive 768/2008/EC on a common framework for the marketing of products. |
|---|---|
| document | COM(2011)763  |
| date | November 21, 2011 |
The directives should also be aligned with the terminology and provisions of the Lisbon Treaty. In particular the new provisions on comitology must be introduced as a number of the directives concerned established committees.
The selection of the directives concerned
Following adoption of the NLF in July 2008, the Commission services screened product legislation to identify instruments due to be revised within the next 3-5 years (i.e. up to 2013) for sector-specific reasons (e.g. to clarify or expand their scope, to update safety requirements etc.). Most existing legislation required updating for sector-specific reasons and these individual revisions appear in the Commission Work Programme. Alignment will take place in the context of these revisions.
The Commission also looked for legislation which largely shared the structure and approach of the provisions of Decision No 768/2008/EC to form part of an exercise devoted solely to alignment with the Decision. This automatically limited the choice of directives to those adopted under the New Approach technique, as other legislation (in particular old or traditional approach directives) would require more in depth adaptation going beyond mere “alignment”.
This process led the Commission to identify the following ten new approach directives for inclusion in this alignment package:
- Civil Explosives Directive: Directive 93/15/EEC on the harmonisation of the provisions relating to the placing on the market and supervision of explosives for civil use;
- Directive on equipment for use in explosive atmospheres (ATEX): Directive 94/9/EC on the approximation of the laws of the Member States concerning equipment and protective systems intended for use in potentially explosive atmospheres;
- Lifts Directive : Directive 95/16/EC on the approximation of the laws of the Member States relating to lifts;
- Pressure Equipment Directive: Directive 97/23/EC on the approximation of the laws of the Member States concerning pressure equipment;
- Measuring Instruments Directive: Directive 2004/22/EC on measuring instruments;
- Electromagnetic Compatibility Directive (EMC): Directive 2004/108/EC on the approximation of the laws of the Member States relating to electromagnetic compatibility;
- Low Voltage Directive (LVD): Directive 2006/95/EC on the harmonisation of the laws of Member States relating to electrical equipment designed for use within certain voltage limits;
- Pyrotechnic Articles Directive: Directive 2007/23/EC on the placing on the market of pyrotechnic articles;
- Non-automatic Weighing Instruments Directive: Directive 2009/23/EC on non-automatic weighing instruments;
- Simple Pressure Vessels Directive : Directive 2009/105/EC relating to simple pressure vessels.
The major common characteristic of these directives is that they have a similar structure: definitions, essential health and safety requirements, references to harmonised European standards, requirements for manufacturers, traceability requirements and conformity assessment requirements (all have conformity assessment procedures, eight require the intervention of notified bodies) and safeguard mechanisms.
Some of the directives have cross sectoral relevance (in particular, low voltage, EMC, measuring instruments, equipment for use in explosive atmospheres and pressure equipment) thus reinforcing the expected benefits of alignment for economic operators and national authorities responsible for the surveillance of these markets.
The sectors concerned are very important industrial sectors which are faced with severe international competition and will therefore benefit from simplification and the guarantee of a level playing field in the EU market.
Basic data for some of these sectors can be summarised as follows:
The low voltage and EMC directives cover in general all domestic and professional electrical appliances which answer to an output of some € 235.59 billion for equipment covered by LVD and € 200.12 billion for equipment covered by EMC. The trade balance is negative (LVD: € 103.93 billion of imports and € 83.09 billion of exports. The internal consumption is estimated at € 256.42 billion. EMC: € 100.78 billion of imports and € 76.07 billion of exports. The internal consumption is estimated at € 224.83 billion).
The ATEX equipment directive covers any product likely to be used in an explosive atmosphere, whether electrical, mechanical or pressure driven (mines, petrochemical plants, mills, filling stations. etc). The output is to the order of some € 2.2 billion, and its trade balance is positive: imports amount to € 400 million, whereas internal consumption estimated at € 1.9 billion, 86% of internal production.
The sector of measuring instruments (including non-automatic weighing instruments) which covers all measuring meters for water, gas, electricity, petrol and all other liquids and includes all weighing instruments in retail commerce has an output of some € 5.75 billion. Most instruments are manufactured in the EU, imports representing less than a quarter of EU production.
Pyrotechnics, which cover not only fireworks but also the technology for automobile air-bags, has an output of € 4.2 billion (€ 2.8 billion for airbags). The fact that 95% of fireworks are produced outside the EU underlines the need for strong traceability requirements.
Pressure equipment (including simple pressure vessels) may fall under several different sectors as it is mostly used as a component in a larger end product. Goods including pressure equipment range from consumer goods (e.g. pressure cookers, domestic air conditioning systems, fire extinguishers, etc.) to industrial goods (e.g. pressure vessels and piping in chemical plants, various types of machinery, etc.).
This clearly shows the importance of the sectors concerned and underlines that enhancing legislative coherence and enabling effective market surveillance, in particular in relation to goods originating in third countries, will have very positive effects.
The contents of the proposals
The proposals covered by this initiative are strictly limited in content to alignment with Decision No 768/2008/EC and the new terminology of the Lisbon Treaty (including the new provisions on comitology). More specifically, they will align definitions, traceability requirements, obligations of economic operators, criteria and procedures for the selection of conformity assessment bodies (notified bodies) and conformity assessment requirements.
The language used in the provisions of the Decision has been retained as far as possible, but in certain circumstances it has been adapted to enable correct and meaningful integration into the directives. Thus, terminology may differ from one directive to another but the meaning and legal obligations will be the same.
The substance of the alignment of the ten directives can be summarised as follows:
1. Measures intended to address the problem of non-compliance:
2. Obligations of importers and distributors to check that goods bear the CE marking, are accompanied by the required documents and carry traceability information. Additional obligations are imposed on importers.
3. Obligations of manufacturers to provide instructions and safety information in a language easily understood by consumers and end-users, and to carry out sample testing and product monitoring .
4. Traceability requirements throughout the whole distribution chain: manufacturers and importers must put their names and addresses on products; every economic operator must be able to inform the authorities from whom he purchased a product and to whom he supplied it .
5. Reorganisation of safeguard clause procedure (market surveillance) to clarify how the relevant enforcement authorities are informed about dangerous goods and ensure that the same action is taken in relation to that product in all Member States.
6. Measures intended to ensure the quality of work done by notified bodies:
7. Reinforcement of the notification requirements for notified bodies (including subcontractors and subsidiaries) such as impartiality, competence in carrying out their activity and the application of guidance developed by coordination groups.
8. Revised notification process : Member States notifying a body must include information on the evaluation of the competence of that body. Other Member States can object to the notification within a certain period.
9. Requirements for notifying authorities (i.e. the national authorities responsible for the assessment, notification and monitoring of notified bodies) such as objectivity and impartiality in carrying out their activity.
10. Information obligations : Notified bodies must inform notifying authorities of refusals, restrictions, suspensions and withdrawals of certificates.
11. Measures intended to ensure greater consistency among directives:
12. Alignment of commonly used definitions and terminology .
13. Alignment of the texts of the conformity assessment procedures .
It should be underlined that issues relating to the implementation of EU standardisation policy, which could have knock-on effects on the implementation of the directives covered here, are being dealt with in a separate initiative (the standardisation package).
Conclusions
The Commission attaches great importance to these proposals, which make an important contribution to the political goal of a properly functioning internal market for consumers, professionals and economic operators in general. The aligned directives will help strengthen the competitiveness of European enterprises, guaranteeing a level playing field for all where law-abiding operators will be protected against those less scrupulous.
This initiative is also very much in line with the Commission’s objective of Better Regulation and Simplification, as it brings coherence and legislative uniformity across many different industrial sectors, helping to make EU legislation easier to understand, implement, obey and enforce.
The Commission has selected instruments for this package on the basis that the only amendments made to them relate to alignment with the provisions of the NLF. No changes are made to the substantive technical aspects of the particular sectoral legislation involved[4]. Accordingly, the Commission calls upon the European Parliament and Council to treat the package as such in order to ensure the overall coherence implicit in the recast technique and to avoid splitting up debates into a collection of sectoral discussions.
[1] COM(2011) 206 final of 13.4.2011.
[2] Communication from the Commission to the European Parliament and the Council: Enhancing the Implementation of the New Approach Directives, COM(2003) 240 final of 7.5.2003.
[3] OJ L 170, 30.6.2009, p. 1.
[4] An exception is made for the pyrotechnic articles directive. The Commission proposes a small correction to Annex I point (4) in order to avoid an unintended ban of airbags and certain other pyrotechnic articles after 4 July 2013. The amendment is relatively minor in terms of changes made to the existing text. Hence it is considered more appropriate and efficient to keep the directive inside the package instead of carrying out an independent revision process.