HCR Law Events

22 September 2020

Regulatory law and Brexit – changes due in product manufacturing

The regulatory matrix under which businesses must operate in the 21st century derives only in part from EU law and much of that has already been adopted into UK law. At the end of the transition period, businesses will still have to abide by the many and varied laws on money laundering, bribery, corporate governance etc. Health and safety law will largely remain the same. One area in which there are impending changes is product manufacturing.

Health and safety at work

Businesses’ responsibility to protect the health and safety of people affected by their work activities has remained the same during the transition period and will continue to do so. The HSE has already declared that it will continue to regulate work equipment in particular.

A couple of esoteric points:

  • From 1 January 2021, applications to make biocidal active substances and products available on the UK market must be submitted to HSE. How HSE will process these applications is currently being finalised.
  • New rules from January 2021 will ensure the safe and secure management of civil explosives and the HSE will retain its role in regulating explosives when the transition period ends.

Product manufacturing

If your goods are already on the UK market (or in an EU country) before 1 January 2021, you do not need to do anything as regards the product itself. If not, you need to be aware of the new rules.

Placing manufactured goods on the market in England, Wales and Scotland

If you have not already placed your goods on the market in Great Britain (different rules apply for Northern Ireland) before 1 January 2021, what you need to do depends on the type of goods and whether they are regulated under the old approach (such as chemicals, medicines and vehicles), under the new approach (which use the CE marking), or are non-harmonised goods covered by national legislation.

On a general level, manufacturers and distributors will all need to be aware of changes in conformity or assessment marking of goods which will change at the end of the transition period.

From 1 January 2021, the UKCA mark will be the conformity assessment marking for Great Britain for most goods currently subject to CE marking.

CE marking will be accepted in the UK until 1 January 2022 for a very limited number of products.

Manufacturers must be ready to use the UKCA marking from 1 January 2022 at the latest.

You will need to use the new UKCA marking immediately after 1 January 2021 if all of the following apply. Your product:

  • is covered by legislation which requires the UKCA marking
  • requires mandatory third-party conformity assessment
  • conformity assessment has been carried out by a UK conformity assessment body but you have not transferred your conformity assessment files from your UK body to an EU recognised body before 1 January 2021.

UK distributors and suppliers will need to consider whether they will become an ‘importer’ after 1 January 2021, if they are bringing goods into the UK from outside the UK and placing them on the market in Great Britain. If so, ‘importers’ must discharge their own obligations in relation to labelling and conformity assessment.

Placing manufactured goods on the EU market from 1 January 2021

If goods are already on the market in an EU country (or in the UK) before 1 January 2021, manufacturers do not need to do anything as regards the product itself.

If not, what manufacturers need to do from 1 January 2021 again depends on the type of goods.

More generally, manufacturers must check that the goods they will place on the EU market bear CE marking.

The UKCA marking will not be recognised on the EU or Northern Ireland markets. Products currently requiring a CE marking for sale in the EU will continue to need a CE mark.

Manufacturers need not take any action from 1 January 2021 if they self-declare the conformity of goods against the regulations or they voluntarily use a testing or notified body to test against European or international standards.

Manufacturers will need to take additional action if their goods need third-party conformity assessment. They should first check if their current UK notified body is taking action. If not, a manufacturer may need apply for a new certificate from an EU notified body.

UK manufacturers with an EU based distributor should also remember that their distributor will become an ‘importer’ from 1 January 2021 and will take on their own responsibilities under EU law for labelling and conformity assessment.

The government advises all those involved in the sale of goods to contact their trade association or solicitor to avoid inadvertently breaking the new rules.

Our regulatory team advises a wide variety of business sectors and individuals on all regulatory laws – for more advice and information, please contact Ruth Sheret at rsheret@hcrlaw.com or on 07890 625 156.

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Ruth Sheret, Senior Associate

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