The Committee on the Internal Market and Consumer Protection adopted the report by Ivan ŠTEFANEC (EPP, SK) on the proposal for a regulation of the European Parliament and of the Council on machinery products.
The committee recommended that the European Parliament's position adopted at first reading under the ordinary legislative procedure be amended as follows:
Subject matter and scope
Member stated that the Regulation lays down requirements for the design and construction of machinery products to allow the making available on the market or putting into service of machinery products and establishes rules on the free movement of machinery products in the Union, ensuring a high level of protection for Union consumers and professional operators.
The following should be excluded from the scope of the Regulation:
- vehicles which have as their only objective the transport of goods, persons or animals by air, water or rail except for machinery mounted on those vehicles;
- motor vehicles and their trailers, as well as systems, components and separate technical units, parts and equipment designed and constructed for such vehicles, which fall within the scope of application of Regulation (EU) 2018/858, except for machinery mounted on those vehicles;
- motor vehicles intended exclusively for competition.
Machinery mounted on two- or three-wheel vehicles and quadricycles as well as on agricultural and forestry tractors should be covered by Regulation (EU) 2018/858.
Clarification of definitions
The report proposed to clarify certain definitions, such as ‘safety component’, ‘substantial modification’ and ‘manufacturer’, and suggested adding new definitions, namely ‘machine and related products’, ‘safety function’, ‘technical documentation’ and ‘lifetime’, to make the scheme more understandable.
Members also considered it necessary to make a clearer distinction between the definitions that apply to ‘partly completed machinery’ and those that apply to other categories of machinery and related products.
High-risk machinery and related products
Members proposed to replace the term ‘high-risk machinery and related products’ with ‘categories of machinery and related products subject to the specific conformity assessment procedure’ (Annex I, Part A).
The Commission could adopt delegated acts to amend Annex I, after consulting the relevant stakeholders, by adding a new machine or related product to the list of categories of machinery and associated products in Annex I, or by removing a machine or related product from that list. Where a new machine or related product is added to the list in Annex I, the Commission should ensure that economic operators have sufficient time to comply with their obligations under the Regulation.
Machinery and related products which present a risk to human health taking into account their design, intended purpose and any foreseeable use would be added to the list of categories of machinery and related products in Annex I.
A machinery product that is established as posing a risk to human health should be included in the list of categories of machinery products in Annex I, Part A, if at least one of the following conditions is fulfilled:
- no harmonised standards or technical specifications covering all the relevant essential health and safety requirements exist for the category of the machinery product in question;
- residual risks due to shortcomings of protective measures exist and information communicated to the Commission in accordance with paragraph 4 demonstrates a recurrence of serious or fatal accidents or damage to health in relation with these residual risks;
- statistics on accidents referred to in paragraph 4 demonstrate either shortcomings in the relevant harmonised standards or technical specifications or a recurring incorrect application of the relevant harmonised standards or technical specifications;
- the degree of uncertainty of the potential risk related to new types of machinery or technologies.
A machine or related product that is found to present a risk to human health and that does not fulfil any of these conditions should be included in the list of categories of machinery and related products in Annex I, Part B.
Partly completed machinery
Partly completed machinery should only be made available on the market if it complies with the relevant essential health and safety requirements set out in Annex III, and if the manufacturer has declared this to be the case in the EU Declaration of Incorporation.
Documents
All relevant technical documentation, assembly instructions and declarations should be available in paper form or electronically and, where electronic, should be accessible throughout the life cycle of the machinery or related product.
Presumption of conformity of machinery and related products
If harmonised standards covering the essential health and safety requirements set out in Annex III are developed and references to these standards are published in the Official Journal of the European Union in accordance with Regulation (EU) No 1025/2012, the relevant technical specifications should no longer apply.
Procedure applicable at national level
Where the market surveillance authorities of a Member State have sufficient reason to believe that a machine or related product does not comply with the requirements set out in the Regulation or presents a risk to the health or safety of persons and, where appropriate, domestic animals or to property and, where applicable, the environment, they should carry out an evaluation in relation to the machinery product concerned covering all relevant requirements laid down in this Regulation.
Where the relevant economic operator does not take corrective action referred to in the Regulation, within the specified period or where the non-compliance or the risk persists, the market surveillance authorities should ensure that the machinery product concerned is withdrawn or recalled, or that making available on the market is prohibited or restricted, and that the public, the Commission and the other Member States are informed accordingly without delay.
Deadlines and transitional arrangements
The report proposes to extend the deadline for repealing Directive 2006/42/EC from 30 to 48 months after the date of entry into force of the new Regulation. Member States should not prevent the making available on the market of machinery that has been placed on the market in accordance with Directive 2006/42/EC before the date of application of the Regulation.
The deadline for the Commission to submit its first report on the evaluation of the Regulation would be extended from 54 to 72 months. Lastly, the date of application of the regulation has been postponed from 30 to 48 months after its entry into force.