Explanatory Memorandum to COM(2000)899 - Machinery - Main contents
Please note
This page contains a limited version of this dossier in the EU Monitor.
| dossier | COM(2000)899 - Machinery. |
|---|---|
| source | COM(2000)899  |
| date | 26-01-2001 |
Council Directive 89/392/EEC i of 14 June 1989 on the approximation of the laws of the Member States relating to machinery, more generally known as the Machinery Directive, entered into force on 1 January 1993 and has been fully applicable since 1 January 1995. It was amended by Council Directives 91/368/EEC i, 93/44/EEC i and 93/68/EEC i. All of these Directives have been fully applicable since 1 January 1997.
These texts were consolidated by Directive 98/37/EC i of the European Parliament and of the Council of 22 June 1998 on the approximation of the laws of the Member States relating to machinery.
Contents
- 2. REASONS AND OBJECTIVES
- 3. LEGAL BASIS
- 4. IMPORTANCE OF THE SECTOR COVERED BY THE DIRECTIVE
- 5. THE TEXT MUST BE ACCESSIBLE AND EASY TO APPLY
- 6. PROPORTIONALITY
- 7. FOLLOW-UP TO THE MOLITOR REPORT
- 8. CONTENT OF THE DIRECTIVE
- Articles
- Annex I - Essential health and safety requirements
- Annex II - Declarations
- Annex IV - Categories of potentially hazardous machinery
- Annexes V and VIII on partly completed machinery and intrinsically safe machinery
- Annexes VI, VII, IX, X and XI on conformity assessment
- Annex XII - Minimum criteria for notification of bodies
- 9. CONSISTENCY WITH OTHER COMMUNITY POLICIES
- 10. EXTERNAL CONSULTATIONS
- 11. EVALUATION
Anxious to demonstrate greater efficiency and transparency to the outside world, the Commission undertook to eliminate excessive red tape and to simplify the implementation of legislative texts.
With this in mind, the Commission, supported by the Council, considered it necessary to seek the views of a number of individuals not directly involved in the drafting and administration of directives. In September 1994, it therefore set up a high-level group of independent experts from various backgrounds (industry, trade unions, universities, the judiciary and the civil service) who were asked to assess the impact of Community and national legislation on competitiveness and employment and to make recommendations to the Commission. This group was chaired by Dr Bernhard Molitor and drew up general proposals which were applicable to all of the directives. It also considered a number of individual directives, including the Machinery Directive.
This proposal for a Directive has been prepared on the basis of those proposals and of the Commission's comments on the report issued by the group of independent experts i (18 general proposals and 12 relating to the Machinery Directive). It also takes account of the experience gained in the practical application of the amended Directive 89/392/EEC.
This proposal for a Directive amends Directive 98/37/EC. Given the scope and number of these amendments, and in order to make the text more comprehensible, it is presented as a recast directive rather than a directive amending Directive 98/37/EC.
The various parts which have been amended are underlined. The Commission wishes to emphasise that only these underlined sections form part of the recasting proposal.
This proposal for a revision of the Machinery Directive is based on Article 95 of the Treaty which sets out the principles for the establishment of the internal market. The Machinery Directive ensures the free movement of machinery falling within its scope and which satisfies the essential requirements laid down in it in respect of safety, health and consumer protection.
The principles of the New Approach, set out in the Council Resolution of 7 May 1985, apply. The draft spells out the essential health and safety requirements with which the machinery must comply before being placed on the market and/or put into service, as well as the conformity assessment procedures applicable. While the Directive details the objectives to be attained, the European standardisation bodies, i.e. CEN, CENELEC and ETSI, are responsible for the practical means of fulfilling these essential requirements.
This proposal for a Directive is of relevance for the European Economic Area (EEA).
Although there are no statistics relating to the area covered by the Directive, it is possible to use as a basis statistics covering the engineering industry, which includes machinery, mechanical apparatus and components.
With a production of around EUR 300 billion in 1998 (EUR 314 billion if EFTA members are included), the engineering sector makes up approximately 8% of the Union's industry.
As a producer of the capital goods needed in agriculture, mining, the construction industry, transport and all other industrial sectors, the engineering sector plays a key role for the economy as a whole. The competitiveness of the other sectors of the economy is therefore heavily reliant on equipment and installations provided by the engineering industry.
In terms of production volume, the European Union leads the world in this sector together with the United States, and is ahead of Japan. The sector employs over 2.2 million engineers, technicians and workers, mostly highly skilled, in the 15 Member States.
The European Union is by far the largest exporter of machinery and mechanical equipment, totalling EUR 113 billion; it is followed by the United States (EUR 66 billion) and Japan (EUR 57 billion). Of all the industrial sectors, it is the engineering sector that generates the European Union's largest trade surplus.
With annual sales of EUR 227 billion, the European Union's engineering market is second in the world, after the United States, in terms of consumption.
In addition to the Molitor report which advocated, among other things, a better definition of various concepts, the Commission has endeavoured to clarify the procedures described by the Directive. To this end, it has explained the conformity assessment and market surveillance procedures so as to avoid differing interpretations of these procedures.
This proposal contains two major changes to the scope.
The first concerns the inclusion of portable cartridge-operated devices, such as fixing tools, stunning pistols, marking guns etc, where the cartridge is not direct-acting. At present, these are excluded from the Directive because they are regarded as firearms, even though they fully comply with the definition set out in the Directive. It therefore seems expedient to include them so that they can benefit from freedom of movement within the European Union. Appliances in which the cartridge is direct-acting can be considered as firearms and naturally remain outside the scope of the Directive.
The second proposal concerns construction site hoists intended for lifting persons or persons and goods. At the moment there is no European legislation in this area. Construction site hoists intended for lifting persons or persons and goods are explicitly excluded from the Machinery Directive 98/37/EC and the Lifts Directive 95/16/EC i, although they can in fact be treated in the same way as other appliances for the lifting of persons under this Directive. There is no reason to make an exception for them, and it is altogether logical that they be included.
All the parties concerned, especially industry and workers' representatives, have readily accepted Directive 98/37/EC. It has led to an improvement in the safety of machinery placed on the market since its application. It is considered as being suited to market demands and observes the principles of subsidiarity and proportionality as Community texts are required to do.
The general proposals in the report of the Molitor Group have been taken into consideration, in particular:
- Proposal 6, which sets out the criteria to be met by each legislative proposal (clear and understandable provisions, consistency with existing Community legislation, etc.). The proposed text meets all of these criteria;
- Proposal 8 requires that all parties concerned be consulted before a proposal is drawn up. The preliminary draft has been the subject of numerous discussions in which all the parties concerned (Member States, consumers, enterprises, workers) have been associated.
The specific proposals put forward by the Group which are germane to the Machinery Directive are set out below:
- the first proposal concerns the definition of machinery. This proposal has been followed, the definition of machinery covered by the Directive has been improved and the machines to be excluded have been clearly identified;
- the second proposal, with regard to placing on the market, has been taken into account. The concepts of 'placing on the market', 'putting into service', 'manufacturer' and 'authorised representative' have also been clarified so as to avoid divergent interpretations by economic operators. As for placing on the market, it has been made quite clear that this refers to the moment when the machine is first made available on the territory of the European Union;
- the third proposal, namely that the Directive should apply only to complete ready-for-use machines, has been followed. The definition of partly completed machinery (formerly called subassemblies), which must be allowed to move freely within the European Union, has been clarified. Such machines are not subject to all of the Directive's provisions but only to the following two requirements:
- a declaration of incorporation in its present form;
- assembly instructions, which must be part of the technical file of the complete machine.
By the same token, components are not included in the text of the Directive.
- The fourth proposal concerns the CE marking and calls for the uncertainties surrounding the affixing of this marking to be removed. The Commission ascertained that other marks were being used to indicate conformity with the essential health and safety requirements, in some cases applying conformity assessment procedures which differed from those required by the Directive. It was not possible to improve on this point in this text. There appears to be a need for a proposal which applies equally to all the New Approach directives, as simply improving the text of the Machinery Directive would not satisfactorily resolve this problem.
- The fifth proposal relates to the market for second-hand machinery. The text of the Directive makes it very clear that it refers only to the making available for the first time in the territory of the Union; the use of second-hand machinery falls within the scope of Directive 89/655/EEC i, as amended by Directive 95/63/EC i.
- The sixth proposal refers to the overlap with Directive 73/23/EEC i, as amended, on electrical equipment designed for use within certain voltage limits (known as the Low-Voltage Directive) and has received considerable attention because of the numerous difficulties it has caused for the application of the existing Directive. The text has been made more explicit in order to avoid the danger of overlapping.
- The seventh proposal concerns the relationship with Directive 92/59/EEC i on general product safety (GPS), which is currently being revised. The provisions of the GPS Directive do not apply to products covered by the New Approach directives in as much as those directives contain specific provisions having the same objectives and same presentation as the GPS Directive. For instance, this proposal does not include an early warning system for dangerous products which need to be withdrawn rapidly from the Community market. It is necessary, therefore, in the case of products intended for consumers, that the Community system for the rapid exchange of information and, where appropriate, the necessary emergency measures should apply as provided for in the GPS Directive. Claims against products must be settled under the safeguard clauses described in the various directives applicable.
- The eighth proposal concerns the list of machines for which more stringent conformity assessment needs to be applied. Although the number of machines has been reduced in this proposal, it has not been possible, in view of the major hazards presented by the machines in question, to futher shorten this list. Moreover, the various conformity assessment procedures have been brought into line with the procedures described in Decision 93/465/EEC i concerning modules.
- Secondly, a full quality assurance procedure has been added to the various existing possibilities, in order that the industry is no longer obliged to submit every new machine for examination by a notified body. This procedure, which may be used at the manufacturer's discretion, seems particularly interesting for those who manufacture machines individually or in very small numbers.
- It has not been possible to follow up the ninth proposal relating to machines manufactured in accordance with harmonised standards, for the reasons set out in the Commission's comments to the proposals, which are quoted below: 'In the case of compliance with the harmonised standards, the procedure has already been simplified in that the manufacturer will not have to demonstrate how the means used meet the essential requirements. However, this does not imply that the declaration of conformity suffices. In particular, the declaration and the technical file serve different objectives - one signifies the responsibility of the manufacturer who places the product on the market, while the other provides the results of the tests conducted, applying the standards. Consequently, the declaration of conformity cannot be considered a substitute for the technical file. Finally, the approach proposed would conflict with the global approach to certification followed since 1990 and applied to all the New Approach directives since then.'
- The tenth proposal, concerning languages, has been carefully examined and clearer provisions have been included in Annex I, point 1.10.1. It became clear, however, that a translation alone was not sufficient to guarantee manufacturers' rights, because they are only 'responsible' for the original notice(s).
- The eleventh proposal concerns guides for users of the Directive. The Commission had proposed a new structure for Annex I 'Essential health and safety requirements' based on the hazards posed by machinery (general requirements plus specific requirements for the various categories of equipment). This new presentation would have made it easier to apply this Annex. This proposal was rejected both by the Member States and by the representatives of industry, who preferred to keep the existing structure (based on the different categories of machinery). The Commission intends to prepare guides (in the form of comments) for the use of each category of machinery. The social partners concerned will naturally be involved in this drafting exercise.
- The twelfth and last proposal concerns harmonised standards. The Commission would point out that, while agreeing that harmonised standards must form complete sets and be relevant in market and commercial terms, European standardisation is a private-sector process over which it has only limited influence. It also points out that the social partners as a whole, and industry in particular, are extremely closely involved in the choices made by the various technical standardisation committees.
A majority of Member States would like to see a tightening-up of the rules on market surveillance so as to allow a genuine circulation of information. The amendments thus seek to strengthen cooperation between Member States in order to provide a clear legal basis for exchanges of information and to ensure observance of professional secrecy where this proves necessary.
The Commission is currently examining the need for a supplementary proposal on this matter.
In conclusion, the purpose of the work that has gone into the revision of the Machinery Directive has been to simplify its application and make it easier to interpret, on the basis of the experience acquired since its entry into force in the Member States and of the conclusions of the Molitor report. Economic operators need a stable legal framework that is conducive to the development of the internal market, in order to manage their present and future activities more effectively.
As this Directive is a recast of Directive 98/37/EC, which has been applied in its entirety since 1 January 1997 and partially since 1 January 1993, this chapter indicates only the major amendments to the text.
Article 1 has been very substantially amended to take account of comments to the effect that not all of the products referred to in the Directive are machines in the strict sense of the word. The new definition takes account of this aspect and clearly identifies partly completed machinery, to which the Directive does not apply in its entirety.
A number of definitions have been added to make it easier to interpret the text. In the case of safety components, it was decided to present an exhaustive list of machinery rather than a definition (the text of Directive 98/37/EC contains such a definition and it has given rise to many problems of interpretation). In order to take account of technological development, the Machinery Committee set up by the Directive will have the powers to amend this list.
A number of machines which were not in Directive 98/37/EC have been included within the scope of the Directive:
- devices for the lifting of persons with reduced mobility;
- construction site hoists intended for lifting persons or persons and goods;
- cartridge-operated fixing devices.
This latter category is the subject of a convention signed by 13 states i, including eight Member States, under the auspices of the Permanent International Commission for the Proof of Small Arms (CIP) i. This Convention requires all products placed on the market by one of the signatory countries to be examined by an authorised body and to be stamped. Member States will have to ensure that there is compatibility between the Convention and the obligations arising from this Directive.
In accordance with Council Decision 1999/468/EC of 28 June 1999 i laying down the procedures for the exercise of implementing powers conferred on the Commission, the Machinery Committee set up by the Directive has been divided into two distinct parts, one using the regulatory procedure to work on clearly defined tasks, the other playing an advisory role on all matters raised by the implementation and practical application of the Directive.
The possibility of prohibiting potentially dangerous machinery has been introduced; the Member State must ascertain this fact, take precautionary measures and inform the Commission and the other Member States thereof. After scrutiny, prohibitive Community measures may be taken by the Machinery Committee set up by the Directive (under the regulatory procedure).
The procedures for disputing harmonised standards and the safeguard clauses are set out in separate articles.
As regards the conformity assessment of machinery referred to in the Directive, the distinction between machinery as a whole and machines which present more serious hazards (quoted in Annex IV) has been maintained. For the first category only conformity assessment with internal inspection (Annex VII) applies; for the more hazardous machines, the manufacturer or his authorised representative may choose to apply either adequacy in respect of harmonised standards (Annex IX), EC type-examination of the machine (Annex X) or full quality assurance (Annex XI). It should be noted that it is no longer possible, in cases where a machine is manufactured in accordance with harmonised standards, to lodge the technical file with a notified body which takes receipt without examining it. Moreover, a simplified procedure has been introduced for machinery which is referred to by the Directive but which presents no inherent risk to safety and health (Annex VIII).
Partly completed machinery, which is almost a machine but which cannot itself perform a specific application, is required to meet only two obligations, namely to bear a declaration of incorporation (Annex II, part B) and to be accompanied by assembly instructions (Annex V).
In order to ensure that the laws, regulations and administrative provisions existing in the various Member States relating to the installation and use of machinery are transparent, Member States are now required to inform all parties concerned and the Commission of all existing and future provisions which they intend to apply.
Article 17 deals specifically with non-conforming markings and describes the obligations arising from the affixing of the CE marking on a machine that is not covered by the Directive or the absence of CE marking for a machine that is so covered.
To ensure total consistency between the scope of this Directive and of Directive 95/16/EC on lifts, an Article amending the latter Directive has been added (Article 24).
Two articles (Articles 18 and 19) have been introduced, the first to describe the necessary cooperation between Member States, and the second to ensure the necessary confidentiality in exchanges of information relating to the application of the Directive.
The essential health and safety requirements set out in Annex I have not been fundamentally changed; the numbering of the various points has been maintained wherever possible. Many of the changes to the original text concern the drafting, and the most important changes are set out below:
- a number of requirements contained in the existing text for machinery involving a hazard due to its moving parts or for lifting machinery have been extended to cover all machinery. This involves in particular:
- sudden movement during handling (point 1.1.6);
- certain provisions relating to more than one control station;
- the requirement for the operating and/or driving position to be protected against external pollution (point 1.5.1);
- the requirement to provide seating, in particular where machinery is subject to vibrations (point 1.5.2);
- hazards due to lightning (point 1.6.3).
- the parts dealing with instructions (point 1.10 et seq) have been made easier to understand;
- a warning about specific hazards has been added to each of these chapters to draw attention to the fact that the machinery in question must comply with all of the essential health and safety requirements laid down in the Annex;
- specific points have been added to take account of new machinery included within the scope of the Directive.
The essential health and safety requirements are set out by category of machinery, and are supplemented by the following requirements for specific categories:
- agri-foodstuffs machinery and machinery intended for use in the cosmetic and pharmaceutical industries;
- portable hand-held and/or hand-guided machinery;
- portable cartridge-operated fixing devices;
- machinery for working wood and analogous materials;
- machinery presenting hazards due to moving parts;
- machinery presenting hazards due to lifting operations;
- machinery used in underground workings;
- machinery presenting hazards due to an operation involving the lifting or moving of persons;
- machinery designed for lifting persons with reduced mobility;
- construction site hoists intended for lifting persons or persons and goods.
When designing a machine, the manufacturer is required to ascertain from Annex I all of the essential health and safety requirements which he must apply. A wording of Annex I based on hazards and laying a general rule for each hazard, followed by specific cases for the various categories of machinery, would probably have simplified the manufacturer's task.
The Commission intends to prepare explanatory guides for each category of machinery in collaboration with the enterprises concerned.
The contents of the declarations described in Annex II have been amended to take account of the incorporation of safety components into machinery. There are now only two types of declaration: the EC conformity declaration for all machinery and the declaration of incorporation for partly completed machinery.
The list in Annex IV of machinery regarded as most hazardous has been amended to take account of the difficulties of interpreting the existing list, in particular for points 1.1 to 1.4 and 4. Points 14 and 15 have been widened to cover all 'removable mechanical transmission devices' instead of being limited to 'detachable transmission shafts with universal joints'.
Portable cartridge-operated fixing devices have been added to this list of machinery; some machines, on the other hand, have been withdrawn: machines for the manufacture of pyrotechnics, logic units which ensure the safety functions of bimanual controls, roll-over protection structures (ROPS) and falling-object protective structures (FOPS).
A specific annex setting out the assembly instructions for partly completed machinery has been added (Annex V). The same goes for the conformity assessment of a machine not exhibiting any intrinsic health and safety hazard (Annex VIII).
The content of these annexes, which corresponds to the modules set out in Decision 93/465/EEC (Annexes VI, VII, X and XI), has been maintained, although the wording has been changed to make them easier to use.
The technical file which is included in a number of modules is now the subject of a separate annex (Annex VI) so as to avoid this text having to be copied several times.
Annex IX on the adequacy of a machine in respect of harmonised standards has been added to take account of the practice in the 1989 Directive, which was drafted before the modules were adopted. This procedure is a major simplification for manufacturers who have elected to manufacture their machinery in accordance with harmonised standards; deleting it would put firms at a serious disadvantage and would inevitably mean an increase in the cost of applying the Directive.
In Annex IX (adequacy in respect of harmonised standards) and Annex X (EC type-examination), it has been specified that the notified body must keep its technical file for 15 years. This detail does not appear in the modules.
Annex XI on full quality assurance has been amended relative to the corresponding module to make it clear that the manufacturer must, for each of the machines he manufactures, possess a technical file so as to be able to respond to any reasoned request from a Member State which might consider that the machinery in question is defective.
Annex XII, setting out the minimum criteria, reproduces the text of the existing Directive.
There does not appear to be any inconsistency between the Machinery Directive and other Community policies, in particular the directives on the use of machinery (Directive 89/655/EEC as amended).
Over a period of nearly three years, numerous parties were consulted at meetings of the Working Party set up by the Machinery Committee created by Article 6 of this Directive. All parties concerned, both at Member State level and from European federations of manufacturers and trade unions, had an opportunity to express their opinions and make comments. These consultations helped to identify a number of approaches and to overcome difficulties of implementing the existing Directive.
The final version of the proposal for a revised Machinery Directive is the culmination of three successive drafts, each of which has been submitted to the Working Party. It incorporates as far as possible the criticisms, remarks and comments made both by Member States and by European industrial federations and trade unions, in particular the Advisory Committee on Safety, Hygiene and Health Protection at the Workplace.
The assessment of the impact of recasting the Directive on the European economy and on small and medium-sized enterprises in particular is based on a study carried out by an outside body i at the Commission's request.
Carrying out a proper cost-benefit analysis of the draft recast of the Directive for every specific situation is virtually impossible, given the variety of possible situations. Nevertheless, from the conversations with manufacturers and users it has been possible to gather opinions based on their actual experience of the implementation of the existing Directive.
There were a number of reasons for the recasting:
- to improve the legal certainty of the text by providing those responsible for observing and ensuring observance of the Directive with a clearer, more detailed text from which earlier ambiguities had been removed, and providing an answer to the divergent interpretations of the existing text;
- to amend and clarify the scope;
- to maintain the highest possible level of health and safety.
The following conclusions can be drawn from the study.
The Machinery Directive covers a vast number of categories of products. Moreover, there are one hundred or more essential safety requirements. A reading of the new guide published by the Commission in 1999 reveals the number and diversity of technical, legal and practical issues which the Directive raises.
Overall, opinions on the proposed revision are positive. All those consulted agree that the revision of the Directive has improved a number of points whose interpretation had caused uncertainty.
In terms of safety at work, all the experts consulted agree that the revision represents significant progress.
As regards the resulting financial and administrative burden on manufacturers and users, the representatives from industry who were consulted feel that the balance is positive. The savings resulting from the additional level of detail in the new text offset any expenditure generated by a few points of detail.
Certain points require specific clarification.
(a) Interpreting the previous text Those consulted took the view that this objective had been attained. The reformulation of certain requirements was particularly appreciated, as was the definition of the terminology used in the recast version. Safety components The list of safety components in the revised version is restrictive; it will be the task of the committee set up by the Directive to update this list. The fact that the list in the existing text was open gave rise to differences of opinion as to its scope. These differences were a serious handicap for industry. Tying in with the Low-Voltage Directive Another crucial point of interpretation, which was the subject of endless discussions between representatives of the engineering industry and of the electrical and electronics industries, particularly under the heading of standardisation, was the type of electrical equipment to be included in the Machinery Directive. The revised version contains a detailed list of products excluded from the Machinery Directive. This measure has no impact on manufacturers, but undeniably improves the organisation of standardisation work.
(b) Amending the scope The revised version proposes the inclusion of new products into the Directive. Portable cartridge-operated fixing devices
These devices were excluded from the Directive as firearms. They were not allowed to bear the CE marking like competing products which operated using different processes. This revision has been warmly welcomed by the profession. Construction site hoists intended for lifting persons or persons and goods The revised version brings construction site hoists intended for lifting persons or persons and goods back into the Directive, thus filling the legal vacuum which meant that they were not covered by any of the European directives in force. This inclusion also satisfies a request from the industry, which wanted to benefit from the effects of free movement. Motors The formal exclusion of motors, which are already covered by a number of more specific Directives, removes the administrative uncertainty which was troubling manufacturers. It reduces costs by removing the disruption to trade.
(c) Partly completed machinery The existing Directive includes subassemblies. They enjoy the right of free movement provided they are accompanied by a special declaration. However, the concept of subassemblies was open to interpretation and was used in some cases to cover the most elementary components. The revised version now makes it clear that it refers only to machinery that is virtually complete. It requires the purchaser to submit a declaration of incorporation and assembly instructions. Many manufacturers of partly completed machinery already produce these assembly instructions; those who have not done this in the past consider, nevertheless, that the costs involved are lower than the costs resulting from claims against their third-party liability. However, those questioned in industry stressed the importance of a reasonable interpretation of this requirement. The assembly notice should not become an instruction manual on the scale of that required for completed machinery. The cost of this measure is acceptable within the scope and limits of this compromise.
(d) Revision of the essential requirements This point looks only at the small number of essential requirements to which the parties consulted gave particular emphasis.
Controls In the revised version each work station must be equipped with the necessary manual controls. This requirement is neutral provided that it refers to the manual controls necessary for each workstation. It appears disproportionate if it involves duplicating all of the control functions at each work station. As far as controls for mobile machinery are concerned, the revised version calls for the means to be put in place to prevent unauthorised use. This measure could result in the modification of some equipment (system allowing only authorised persons to start up the machine). As long as this is indeed the meaning of this requirement, it is not disproportionate to the increased safety that will result. There is a new requirement for remote controls. This corresponds to the state of the art in this area, provided that it is interpreted in a reasonable manner. Cabs The revised version requires the installation of a cab in every case where the working environment poses a health hazard. The very broad wording of this requirement raises the problem of how to reconcile the obligations of the manufacturer with those of the user. An artificial transfer of responsibility from the user to the manufacturer may result from an excessively strict interpretation of this text, possibly leading to disproportionate additional costs. Lightning The revised version provides that preventive measures must be taken against lightning where the machine is installed outside. This requirement may well prove costly if it is applied indiscriminately to all types of machinery. Machinery intended for the cosmetics industry The Directive extends the hygiene requirements to cover this type of machinery which was previously implicitly included. This looks unlikely to give rise to any additional costs, because manufacturers have already incorporated these requirements.
(e) Administrative procedures and the formal aspects of the Directive Under the terms of the Directive, equipment falling within Annex IV and meeting harmonised standards will require the intervention of a notified body to confirm its conformity on the basis of the technical file or on the basis of the product. The manufacturers concerned regret that the procedure involving the deposition of the technical file without examination has been taken away
On the other hand, the introduction of a quality assurance procedure for machinery subject to EC type-examination represents a very appreciable easing of the financial and administrative burden on manufacturers of single machines or ofmachinery in small quantities. It was virtually impossible to amortise the cost of EC type-examination for each launch of a different model. Quality assurance spreads the costs over the whole production.
Some representatives from the industry were afraid that certain new requirements might be interpreted in an overly strict manner which might go beyond the letter and the spirit of the revised version. Such unwarranted interpretations could generate disproportionate costs. A reasonable reading of the text is an essential precondition for the success of the revised version. To this extent, the revised version constitutes a balanced whole in terms of both safety and the administrative and financial burdens. This text should be favourably received by the economic and social partners, given that it does not introduce a ny radical changes to the existing situation.