Requirements for Machinery

EU requirements: EU Directive 2006/42/EC (the “Machinery Directive”) sets out requirements relating to machinery and related products and components. The requirements include safety objectives for the design and manufacture of machinery, labelling requirements, and the applicable conformity assessment procedures. The Machinery Directive also sets out obligations of manufacturers, importers, and distributors.

If you manufacture, import or distribute machinery or other products in the scope of this legislation, you must comply with the requirements of the Machinery Directive. You must also comply with national laws and regulations in Member States, which implement the Machinery Directive.

Please see below for further information about EU requirements.

UK requirements: The Supply of Machinery (Safety) Regulations 2008/1597 (the "Machinery Regulations") set out requirements relating to machinery and related products and components. The requirements include safety objectives for the design and manufacture of machinery, labelling requirements, and the applicable conformity assessment procedures.

If you manufacture, import or distribute machinery or other products in the scope of this legislation, you must comply with the requirements of the Machinery Regulations for products sold in the UK. Different rules apply to goods you sell in: (1) Great Britain (England, Scotland and Wales); and (2) Northern Ireland. If you also sell these products on Amazon EU website(s), you must also comply with national laws and regulations in EU Member States, which implement the EU's Machinery Directive (2006/42/EC).

Please see below for further information about UK Requirements.

This material is for informational purposes only and it is not intended as legal advice. We encourage you to consult your legal counsel for any concerns about the laws and regulations related to your product. This material only reflects the position at the date of writing and requirements in the EU and the UK may change – particularly in light of the developing position with Brexit. You should refer to current UK Brexit guidance about your products (see below) to learn more about changes that may affect you following the end of the transition period.

I. EU Requirements

What products does the Machinery Directive apply to?

The Machinery Directive applies to machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices; and partly completed machinery.

The Machinery Directive defines “machinery” broadly. If you are uncertain whether your product meets the definition of machinery, please seek appropriate expert or legal advice.

There are a number of exemptions to the Machinery Directive, including, for example, certain electrical equipment in the scope of the Low Voltage Directive and not subject to the Machinery Directive (e.g. Household appliances intended for domestic use), machinery for specific use in fairgrounds and/or amusement parks.

Who has obligations under the Machinery Directive?

The Machinery Directive sets out obligations for manufacturers of machinery and authorised representatives.

• You are a manufacturer if you design and/or manufacture machinery or partly completed machinery yourself, and you are responsible for the conformity of the machinery or the partly completed machinery with a view to its being offered for sale or supply in the EU, under your own name or trademark or for your own use.
• You are also considered a manufacturer if you offer machinery or partly completed machinery for sale, or supply in the EU or put it into service, and there is not someone above you in the supply chain who meets the above definition. This can include importers or distributors.
• You are an authorised representative if a machinery manufacturer has given you a written mandate to perform all or part of the obligations and formalities connected with the Machinery Directive on their behalf.

What are the key requirements of the Machinery Directive?

EU Declaration of Conformity and CE marking

Manufacturers or authorised representatives’ responsibilities include:

• Ensuring that machinery satisfies the relevant essential health and safety requirements set out in Annex I of the Machinery Directive
• Ensuring that the technical file (Annex VII, Part A) is available
• Providing necessary information such as instructions
• Carrying out the appropriate conformity assessment procedure
• Drawing up the EC declaration of conformity and ensuring it accompanies the machinery
• Affixing the CE marking visibly, legibly, and indelibly to the machinery

Where other CE marking directives apply, the marking should indicate that the machinery also conforms to the relevant provisions of those other directives.

Manufacturers and authorised representatives must keep a copy of the technical documentation and EU declaration of conformity for 10 years after the machinery has been offered for sale or supply in the EU.

Labelling and information:

Manufacturers or authorised representatives must ensure that the machinery is marked with :

• The business name, full address of the manufacturer, and wherever applicable, its authorised representative
• Designation of the machinery
• Designation of series or type
• Serial number, if applicable
• The year of construction (the year in which the manufacturing process is completed)
• Full information relevant to type and essential for safe use
• The CE marking

In addition, proper instructions and the EU Declaration of Conformity must accompany the machinery, which should be in the official Community language or languages of the Member State(s) in which it is offered for sale or supply and/or put into service.

Are there obligations on importers and distributors of machinery?

As explained above, the definition of "manufacturer" under the Machinery Directive is broad, and so the obligations above might apply to those who import/distribute machinery in the EU.

In this case, the European Commission’s Blue Guide on the implementation of EU product rules states that it applies to the Machinery Directive. To the extent that there are no specific provisions in the Machinery Directive, importers, and distributors will have obligations under the New Legislative Framework, specifically under Decision 768/2008.

For importers, the responsibilities include ensuring the following:

• The appropriate conformity assessment procedure has been carried out by the manufacturer, the manufacturer has drawn up the technical documentation, and that the machinery bears the CE marking.
• Indicating the importer’s name, registered trade name or registered trade mark, and the address at which they can be contacted on the product, or whenever not possible, on its packaging or in a document accompanying the product.
• The product is accompanied by instructions and safety information in a language which can be easily understood by consumers and other end-users, as determined by the Member State concerned.
• While machinery is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements.

For distributors, this might include:

• Acting with due care in respect of the applicable requirements
• Verifying the product bears the required conformity marking or markings; that it is accompanied by the required documents, instructions, and safety information in a language which can be easily understood by consumers and other end-users in the Member State in which the product is to be sold; and that the manufacturer and the importer have complied with the requirements regarding manufacturer/importer details and conformity assessments.
• Ensuring that while machinery is under their responsibility, its storage or transport conditions do not jeopardise its compliance with the essential requirements.

In addition, Machinery Directive Guidance states that importers and distributors of machinery must ensure that instructions are passed onto the user.

What to do if machinery is not in conformity with the Machinery Directive?

Where machinery marking does not conform with the Machinery Directive, the manufacturer or authorised representative is obliged to make the product conform and to put an end to the infringement. If the non-conformity persists, a Member State will respond appropriately to restrict or prohibit the sale of the product in question or to ensure that it is withdrawn from sale.

Per Decision 768/2008, importers and distributors should:

• Immediately take the corrective measures necessary to bring machinery into conformity, to withdraw or to recall it, as appropriate.
• Inform competent authorities where a product presents a risk, give details, in particular, of the non-compliance and of any corrective measures taken.
• Provide a competent national authority with all the information and documentation, in paper or electronic form, necessary to demonstrate the conformity of a product, following a reasoned request.

Additional Information

We strongly encourage you to visit the European Commission’s website for more information on the Machinery Directive:

• https://ec.europa.eu/growth/sectors/mechanical-engineering/machinery_en
• https://ec.europa.eu/docsroom/documents/24722/attachments/1/translations/en/renditions/native

II. UK Requirements

Where do the Machinery Regulations apply?

The Machinery Regulations apply to all products sold in the UK, but the provisions apply differently to Great Britain (England, Scotland and Wales, "GB") and Northern Ireland. You can read more about the position in Northern Ireland ("NI") below.

What products do the Machinery Regulations apply to?

The Machinery Regulations apply to machinery, interchangeable equipment, safety components, lifting accessories, chains, ropes and webbing, removable mechanical transmission devices; and partly completed machinery.

The Machinery Regulations define "machinery" broadly. If you are uncertain whether your product meets the definition of machinery, please seek appropriate expert or legal advice.

There are a number of exemptions to the Machinery Regulations, including certain electrical equipment which are regulated by the UK's Electrical Equipment (Safety) Regulations 2016/1101, which are not subject to the Machinery Regulations (e.g. Household appliances intended for domestic use, audio and visual equipment, information technology equipment, ordinary office machinery, low-voltage switchgear and control gear and electric motors).

Who has obligations under the Machinery Regulations?

The Machinery Regulations set out obligations for manufacturers of machinery and authorized representatives.

• You are a manufacturer if you design and/or manufacture machinery or partly completed machinery, with a view to it being offered for sale or supply in the UK, under your own name or trademark or for your own use.
• You are also considered a manufacturer if you offer machinery or partly completed machinery for sale or supply, or, put it into service in the UK and there is not someone above you in the supply chain who meets the above definition. This can include importers or distributors.
• You are an authorized representative if a machinery manufacturer has given you a written mandate to perform all or part of the obligations and formalities connected with the Machinery Regulations on their behalf.

What are the key requirements of the Machinery Regulations?

UK Declaration of Conformity and conformity marking

Manufacturers or authorised representatives’ responsibilities include:

• ensuring that machinery satisfies the relevant essential health and safety requirements set out in Annex I of the Machinery Regulations
• ensuring that the technical file (Part 7 of Schedule 2) is available
• providing necessary information for safe operation of the machinery, such as instructions
• carrying out the appropriate conformity assessment procedure
• drawing up the UK declaration of conformity and ensuring it accompanies the machinery
• affixing the conformity marking visibly, legibly, and indelibly to the machinery

Where other conformity marking directives apply, the marking should indicate that the machinery also conforms to the relevant provisions of those other directives.

Manufacturers and authorised representatives must keep a copy of the technical documentation and UK declaration of conformity for 10 years after the machinery has been offered for sale or supply.

Labelling and information:

Manufacturers or authorised representatives must ensure that the machinery is marked with:

• the business name, full address of the manufacturer, and wherever applicable, its authorised representative
• designation of the machinery
• designation of series or type
• serial number, if applicable
• the year of construction (the year in which the manufacturing process is completed)
• full information relevant to type and essential for safe use
• the required conformity marking. The relevant conformity marking is as follows:
  • for machinery sold in the UK until the end of the Brexit transition period (31 December 2020), the European CE mark;
  • for machinery sold in GB after the end of the Brexit transition period (31 December 2020), the UKCA mark;
  • for machinery sold in NI while the Northern Ireland Protocol remains in force, the European CE mark (see "Northern Ireland" section below ).

In addition, proper instructions and a copy of the Declaration of Conformity must accompany the machinery. These must be in English. A specific Declaration of Conformity that refers to UK legislation and standards will be required for products sold in GB with a UKCA mark from 1 January, 2021. See the "BREXIT: UK Government Guidance" section below for links to the UK Government guidance on this.

Are there obligations on importers and distributors of machinery?

As explained above, the definition of "manufacturer" under the Machinery Regulations is broad, and obligations apply to those who manufacture machinery or, where there is no such person, those who supply or put into service machinery in GB.

Additional legislative regimes may apply to machinery which impose obligations on importers and distributors. It is your responsibility to ensure you comply with applicable legislation.

Northern Ireland: Please note that different rules will apply in NI from 1 January 2021 as a result of the Northern Ireland Protocol. In particular:

• You should ensure that products meet EU requirements and that you use the CE mark.
• You have manufacturer obligations if you are established in the EU or NI and you sell products from a country outside of the EU and Northern Ireland (including from GB) into NI. Products sold in NI should be marked with details of any EU/NI based importer.
• Authorised representatives can be based in NI or the EU. From 16 July 2021, new rules come into force under EU Regulation 2019/1020 and some businesses may need to appoint a responsible person in the EU or NI to carry out compliance functions (if there is no other entity in the supply chain who is able to carry out the functions). Further guidance on the new rules will be made available by the UK Government.
• If you are using a UK body to carry out mandatory third-party conformity assessment, you will need to apply a UKNI marking as well as a CE mark to products placed in NI from 1 January 2021. Goods with the CE and UKNI marking can't be sold in the EU. You do not need to use the UKNI marking if you self-certify compliance or use an EU body to carry out a mandatory third-party assessment.
• "Qualifying Northern Ireland goods" will be able to be sold in GB with the CE mark. The UK Government is issuing guidance on how this will work.

What to do if machinery is not in conformity with the Machinery Regulations?

Where machinery does not conform with the Machinery Regulations, but is safe, the manufacturer or authorised representative should immediately take steps to make the product conform and to put an end to the infringement. If the non-conformity means the product is unsafe, or if it persists, the relevant UK Authority (the Health and Safety Executive ("HSE") for machinery for use at work, or Trading Standards for machinery for private use) may take steps to restrict or prohibit the sale of the product in question or to ensure that it is withdrawn and/or recalled from sale. It is an offence to sell non-compliant machinery.

BREXIT: UK Government Guidance

The UK Government has released guidance on selling products in GB and NI after Brexit. This guidance provides information for manufacturers, importers and distributors regarding compliance requirements from 1 January 2021, including on:

• whether you need to change your conformity assessment;
• when and how to use the UKCA mark;
• requirements for technical documentation and a specific Declaration of Conformity for products sold in GB;
• appointing an authorised representative or responsible person in the UK;
• whether your legal responsibilities will change as a result of Brexit;
• whether you need to provide GB importer information, and methods for doing this (including transitional arrangements until the end of 2022);
• how to deal with existing stock;
• what documentary evidence is required to show that products have been placed in the UK or EU before the end of the Transition Period; and
• specific rules for selling products in NI.

We encourage you to review this guidance (linked below), alongside any other specific UK Government guidance that applies to your product. You should consult your legal counsel if you have questions about how the laws and regulations apply to your products from 1 January 2021.

The Brexit guidance can be found here:

GB:

• Placing manufactured goods in Great Britain from 1 January 2021
• Using the UKCA mark in GB from 1 January 2021
• Product Safety and Metrology in GB from 1 January 2021

NI:

• Placing manufactured goods in Northern Ireland from Great Britain
• Placing manufactured goods in Northern Ireland from the EU
• Using the UKNI mark
• Product Safety and Metrology – NI

Additional Information

We strongly encourage you review the below UK Government guidance for more information on the Machinery Regulation:

• https://www.gov.uk/guidance/machinery-manufacturers-and-their-responsibilities

The following HSE guidance also contains information on the impact of Brexit on machinery:

• https://www.hse.gov.uk/brexit/regulating-equipment.htm

We also encourage you to visit the Business Companion website, which contains guidance on UK product compliance rules:

• https://www.businesscompanion.info/en/get-started