Machinery & UKCA marking

TODAY, THE vast majority of UK law is made through Statutory Instruments. The European Union (Withdrawal) Act 2018 and the European Union (Withdrawal Agreement) Act 2020 allowed Statutory Instruments to be made which rescinded and amended legislation which originally emanated from Europe. These Statutory Instruments are referred to as the ‘EU Exit’ Statutory Instruments.

Now that the United Kingdom has left the EU, machinery end-users in the UK will slowly start to see a UKCA mark (UK Conformity Assessed) appearing on compliant products. UKCA marking was specified in the original EU Exit Statutory Instruments and indicates that a product placed on the market meets the UK’s new regulatory requirements. For most products this is defined in UK Statutory Instrument 2019 No. 696, with the original CE marking regulations being amended rather than replaced.

While references to “harmonised standards” have changed to ‘designated standards’, for now the UK standards remain the same as EU harmonised standards and have simply been carried across as UK designated standards in order to maintain a single model. This means that in the UK, procedures have changed very little from the CE marking structure. However, while initially these requirements will align with the CE marking ones that they replace, overtime divergence is possible. The CE marking will of course remain in the EU. In both jurisdictions the same rules will apply for designers, manufacturers, importers and machinery owners - everyone must understand their legal duties and responsibilities.

Since the EU exit transition period came to an end on 31st December 2020, the UKCA marking is now required for new machinery placed on the market for the first time in Great Britain (England, Scotland and Wales), where the involvement of an independent certification body is required. However, machinery manufacturers do have nine months’ grace in the form of a further transitional arrangement for the acceptance of CE marking until 1st January 2022. After this time any machinery sold in the UK, irrespective of when that model was first placed on the market, must carry a UKCA marking. It is therefore vital that machinery end-users understand what  their machinery suppliers should be complying with.

Northern Ireland Protocol

One important issue to be aware of is that additional requirements may need to be considered for products in Northern Ireland (NI) due to separate protocol requirements.

The NI Protocol came into force on 1 January 2021. This means that NI will align with relevant EU rules relating to placing manufactured goods on the market, and CE marking will continue to be accepted. This means that the UKCA mark cannot be used for goods placed on the NI market.

If a UK body carries out a mandatory third-party conformity assessment, then a UKNI marking must be applied, accompanied by a EU conformity marking (e.g. CE marking). Goods with both the CE and UKNI marking cannot be placed on the rest of the EU market. If a mandatory third-party conformity assessment was carried out by an EU-recognised notified body, goods with the CE marking can be placed on NI and EU  markets. For products that do not require third-party conformity assessment, in most cases marking requirements will be satisfied by combined CE and UKCA markings for the GB, EU and NI markets.

The UK government guarantees businesses in NI unfettered access to the UK market, without the need for additional approvals. Qualifying goods can therefore be placed on the GB market based on the conformity markings used in Northern Ireland, such as the CE, and CE/UKNI markings. Qualifying goods are those in free circulation in NI - not under a customs procedure or in an authorised temporary storage facility before being moved between NI and GB.

Machinery supplier responsibilities

Neither the CE or UKCA marking can be applied unless a machine meets the requirements of the Machinery Directive in the EU or the Supply of Machinery Regulation 2008 in the UK, as well as any other applicable directives. The CE/UKCA marking involves a four-step process:

- Essential Health & Safety Requirements (EHSRs)

- Technical Construction File

- Declaration of Conformity

- Affix the CE/UKCA Marking

The EHSR requirements are wide ranging, taking into account potential dangers to operators and other persons who may be at risk. A typical example of an EHSR is the requirement to provide safety guards to machine tools.

The technical construction file proves due diligence and provides evidence of compliance. It is therefore the first document that the authorities will ask for as it provides vital evidence that the correct procedures have been taken during product development. It must also remain available for inspection by a competent national authority, such as the UK Health and Safety Executive, for a period of ten years. However, it does not have to include detailed information such as the sub-assemblies of the machine, unless a knowledge of them is essential for verification and compliance with the EHSRs. The technical file can be a traditional paper file, or stored electronically, with hyperlinks to documents, and it must also be kept up to date as the product is adapted.

The Declaration of Conformity must accompany every machine placed on the market. This is the manufacturer’s assurance to the customer that the product complies with the applicable directives. It must carry relevant product information and be signed by a responsible person on behalf of the manufacturer or importer. This will need to list UK legislation and UK designated standards for compliance. For specific higher risk machinery that requires type-examination by a certification body, a UK Approved Body will be required. From 1 January 2021, UK-based EU notified bodies automatically became UK Approved Bodies for their previous scope of EU accreditation, allowing UKCA certification work to commence.

The alternative to a Declaration of Conformity is a Declaration of Incorporation. This applies to partly completed machinery that is intended to be part of an assembly but cannot itself perform a specific application. This declaration and assembly instructions for the partly completed machinery will then form part of the technical file for the final machinery assembly.

As we do not have an EU / UK Mutual Recognition Agreement (MRA), UK-based approved bodies will no longer be recognised in Europe for CE marking, and EU-based notified bodies will not be recognised as UKCA approved bodies as of 1 January 2021. However, the most significant impact has been on the location of the manufacturer. UK companies exporting CE marked equipment into the EU must appoint a responsible person that is authorised to compile the technical file, and they must be physically located within the EU.

The manufacturer is still allowed to self-declare a product’s compliance where applicable. This responsible person or entity is the same requirement that has been applied for many years to any other country outside of the EU. This is reciprocated for EU entities importing into the UK. Quite simply, post-exit from the EU, the UK is operating a separate regulatory regime just like the rest of the world.

Despite this additional time, the introduction of the new UKCA marking presents machinery manufacturers with the challenge of ensuring compliance with a new conformity assessment mark within a relatively tight timescale. As UKCA markings are a visible sign that a product complies with all the relevant UK regulations, it is essential that machinery end-users understand both their responsibilities and those of their machine’s manufacturer.

Paul Taylor is head of industrial products (UK) at TÜV SÜD

http://www.tuvsud.com/uk