Select Committee on European Scrutiny Second Report


COM(00) 899

Draft Directive on machinery and amending Directive 95/16/EC.

Legal base: Article 95 EC; co-decision; qualified majority voting
Document originated: 26 January 2001
Forwarded to the Council: 26 January 2001
Deposited in Parliament: 13 February 2001
Department: Trade and Industry
Basis of consideration: EM of 23 February and SEM of 2 August 2001
Previous Committee Report: None
To be discussed in Council: No date set
Committee's assessment: Politically important
Committee's decision: Cleared


17.1 In order to further the completion of the Single Market, the Community has since 1989 enacted a number of measures dealing with the safe design, construction and installation of machinery (and components). These were consolidated in 1998 by Directive 98/37/EC, which, with the exception of certain specified categories of machinery,[44] lays down essential health and safety requirements, covering such areas as stability, lighting, control mechanisms (including those for handling emergencies), risks arising from moving parts, protection against other hazards such as fire, noise and vibration, maintenance, and the provision of adequate operating instructions. Member States are required both to take the measures necessary to ensure that machinery placed on the market complies with these provisions, and to ensure that no restrictions are imposed on any items which meet the necessary conditions. The Directive also lays down procedures for assessing conformity with the Directive, and for the granting of the appropriate Community (CE) marking needed to demonstrate compliance. In general, responsibility for certifying conformity rests with the manufacturer, who must draw up the necessary EC declaration, and provide supporting documentation to the relevant national authority (which must keep this available for a minimum of ten years). However, manufacturers of certain types of more dangerous machinery[45] must submit a technical file containing details of the product to a notified body. Depending on whether or not the product has been built to harmonised standards, this requires either a relatively straightforward verification that those standards have been applied or a Community type-examination involving a more extensive series of checks, inspections and tests.

The current proposal

17.2 The current document arises as a result of a more general exercise initiated by the Commission in 1994 to simplify the implementation of Community legislation, including the Machinery Directive. As a result, the following changes have been proposed:

  • a number of definitions would be clarified, and the scope of the Directive expanded to include devices for lifting persons with reduced mobility, construction site hoists, and nail and stud guns (which are currently regarded as firearms): on the other hand, motors would in future be excluded, on the grounds that they are covered by a number of other specific Directives;

  • the current generic definition of safety components would be replaced by a list of such components;

  • responsibility for ensuring the compliance of partially completed machinery would be shifted to the manufacturer of the finished product;

  • machinery which is assessed by the manufacturer as presenting no inherent risk to safety or health would be subject to a simplified compliance procedure (under which a risk assessment would be carried out, but there would be no need to keep a complete technical file, or to compile an EC declaration);

  • however, full quality assurance would be introduced as an alternative to type-examination for goods categorised as presenting more serious hazards;

  • the notified body with whom a manufacturer lodges the technical file for a product conforming to harmonised standards does not at present have to examine this to ascertain whether the standards have been applied correctly: in future, it would be required to do so;

  • the Commission would have new powers to update the detailed safety provisions, with a new Regulatory Committee being set up to provide it with a formal opinion on any proposed changes;

  • any Member State having evidence that a particular piece of machinery is dangerous would be able to make a case to the Community and other Member States for prohibitive Community-wide measures to be taken;

  • Member States would be required to inform all interested parties and the Commission of domestic laws, regulations and administrative provisions relating to the installation and use of machinery, in order to ensure that they are transparent;

  • obligations would be placed on Member States as regards the affixing of the CE marking on machinery not covered by the proposal, or the absence of such a marking for a machine which it covered; and

  • the list of essential health and safety requirements would in certain respects be revised.

In addition, the proposal would amend the scope of Directive 95/16/EC on lifts to ensure consistency with Directive 98/37/EC.

The Government's view

17.3 In his Explanatory Memorandum of 23 February 2001, the Parliamentary Under-Secretary of State for Science and Innovation at the Department of Trade and Industry (Lord Sainsbury of Turville) says that, whilst Directive 98/37/EC is working reasonably well, it is clear that there are problems with certain definitions and uncertainties over its scope, and that the UK therefore supports the idea of clarifying these aspects. It is also supportive of proposals which ease the burdens on manufacturers, whilst recognising the need for a system which protects health and safety and commands the confidence of both consumers and manufacturers.

17.4 However, the Minister also registers a number of reservations. In particular, he says that:

  • the use of a list rather than a generic definition for safety equipment is incompatible with preferred legislative practice, and could lead to further confusion (and possible lacunae) as the state of the art develops;

  • introducing a distinction for partially completed machinery will restrict the ability of market surveillance authorities to investigate problems with components, and could prevent action being taken at an early stage: it could also disadvantage those manufacturers incorporating the components who are not in the best position to demonstrate their compliance;

  • it is inappropriate to seek to prescribe methods of enforcement, particularly for machinery outside the scope of the proposal, as such matters should be the preserve of Member States;

  • the introduction of a new regulatory committee, and of subsequent powers for the Commission to act, are unnecessary, particularly if generic definitions instead of proposed lists continue to be used for the scope of the Directive and its detailed safety requirements;

  • there is no evidence that the present practice of notifying bodies being able to accept technical files without examining them (which still enables a check to be made later if a product is found to be defective) has been abused: ending it would therefore impose a direct cost on manufacturers without any obvious benefit;

  • whilst allowing a system of full quality assurance as an alternative method of compliance will be of benefit to firms which manufacture items in small numbers, it is important to maintain the situation where use of such assurance is voluntary, so that only those enterprises which consider the benefits outweigh the costs need use it;

  • the compliance burden on some manufacturers may be increased by the revision of some of the essential health and safety requirements, and it will be important to ensure that these changes are necessary and proportionate;

  • whilst the proposal to have a very simplified form of compliance for machines which do not present any safety risk seems to offer a simplification, it would introduce a new area of uncertainty for manufacturers; and

  • whilst the changes to Directive 95/16/EC offer some much needed clarification of the respective coverage of that measure and Directive 98/37/EC, the UK is concerned to ensure that this does not produce a situation which encourages the use of inappropriate machinery in place of a classic lift where that may unnecessarily put health and safety at risk.

17.5 The Minister has also provided with his Explanatory Memorandum an interim Regulatory Impact Assessment. This points out that, for most products, compliance is a matter of self-certification by the manufacturer, who is required to keep sufficient records to justify this if required to do so. The main changes would therefore apply to higher-risk products, and would arise in two ways. First, since a manufacturer of such a product will no longer be able simply to deposit the technical file with the notified body, this will give rise to examination costs, ranging from £250-£400 a day. Moreover, since each examination will relate to a product run, this burden will fall more heavily on manufacturers making small quantities of each product. Secondly, and more significantly, application of the full quality assurance procedure could cost around £30,000, plus annual accreditation fees after that. Although there are still other options for compliance, the Assessment suggests that there may be commercial pressures from customers for such an approach, and that, as most manufacturers are small and medium-sized enterprises, this would represent a considerable burden. However, it adds that, although the Government's own consultations will seek to test the Commission's assertion that manufacturers nevertheless consider that the benefits outweigh the costs, initial indications support that view.

Supplementary Explanatory Memorandum of 2 August 2001

17.6 The Minister has now provided us with his Supplementary Explanatory Memorandum of 2 August 2001 a revised Regulatory Impact Assessment. This shows that the proposal has neither high costs nor large benefits associated with it. The latter, which arise from possible additional sales from the inclusion of new items within the scope of the Directive and from safety improvements, are estimated at around £4 million. The former relate mainly to clarifications in the Directive, changes in its scope, and the technical examination of files for machinery posing the greatest risk to the user, and are estimated at £4-5 million per year for the first three years, falling to £1.1 million per year thereafter.


17.7 Whilst the Government has a number of detailed reservations on this proposal, it appears in general to look favourably on the underlying aim of simplifying and clarifying the existing Directive, and it would appear from the figures it has presented that, although the benefits are limited, so too are the potential costs. In views of this, we are clearing the document.

44   These include machines relying only on manual power, those for medical use, steam boilers, machinery designed for nuclear purposes, firearms, various means of passenger transport, machines designed for military or police purposes, and lifts. Back

45   This includes power saws, presses and moulding equipment, and various kinds of underground machinery. Back

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Prepared 2 November 2001