How to ensure the products you make or import comply with the law and are safe for consumers to use.
You need to be able to demonstrate that the products you make or import comply with relevant regulations and meet safety requirements before you put them on the market.
Once a product has been placed on the market, you remain responsible for its safety. You need to provide consumers with adequate information so they can use it safely and ensure it can be traced back to your business if required. You must also monitor its usage and report any risks identified to your local Trading Standards service.
Follow agreed standards
One way to demonstrate compliance with relevant product safety regulations is to follow agreed standards for the design and manufacture of your product type. Certain standards provide a ‘presumption of conformity’, which means that products complying with them are deemed to be safe in relation to the areas they cover.
In Great Britain, new designated standards first published on 1 January 2021 and recognised by the government provide presumption of conformity for businesses placing products on the market.
In Northern Ireland, harmonised standards listed on the European Commission website continue to presumption of conformity for businesses placing products on the market.
Designated standards and harmonised standards were identical at the end of the transition period on 31 December 2020 but may diverge in future.
Some standards are very specific. If no standards exist covering certain safety aspects of your product, you will need another way to demonstrate you have minimised the risks associated with them. (There can be a delay between the introduction of new regulations and the development of relevant standards.)
The British Standards Institute (BSI) website has a comprehensive standards library for UK businesses, including many related to safety.
Carry out a conformity assessment
Conformity assessment is the process that manufacturers must follow for some classes of product before they can be placed on the market. It is a process that enables the manufacturer to make a declaration that the product meets all the requirements that apply to it.
The specific processes for conformity assessment differ between individual products but typically involves:
- product design
- manufacturing process controls
- technical documentation
- product testing
For some products, conformity assessments can be done by the manufacturer. Other products require them to be carried out by an independent organisation.
Those based in the UK are now an Approved Body and a Notified Body, for products placed on the market in Great Britain and Northern Ireland respectively. They can provide conformity assessment to allow the UKCA or UKNI marking to be applied where appropriate. However, approved bodies are not recognised by the EU as competent to apply CE marking alone.
If you’re unsure how the conformity assessment process works for your products, you should refer to the relevant regulations for your industry.
Affix appropriate marking to the product if needed
Certain products require UKCA marking in Great Britain to state that they conform to all relevant UK regulations. CE marking can indicate this in the UK until 31 December 2021, with the exception of products conformity assessed by a UK Approved Body. These must have UKCA marking.
CE marking remains valid in Northern Ireland, including for products sold from there to the rest of the UK. Products that are conformity assessed by a UK Notified Body must also have UKNI marking.
UKCA marking is not recognised in the EU, so certain products still need CE marking in the EU to state that they conform to all relevant European directives.
All marking is applied by the manufacturer and allows the product to be sold in the relevant area without further checks by regulators.
Provide consumer safety information and support traceability
You need to make sure that the packaging and instructions provided with your product clearly communicate all potential risks involved in using it – and what the consumer can do to avoid or lessen those safety risks.
Making your product traceable once it’s on the market is also important for accountability. To enable good traceability, the product itself or its packaging should include:
- the name and address of the manufacturer and importer if there is one
- a product or batch reference that allows you to identify the place and time of manufacture
Monitor product usage and report safety issues
Once your product is on the market, you should continue to monitor its usage and be prepared to respond to any safety risks you identify. You can do this by:
- sampling and testing products
- establishing a process for recording consumer complaints
- keeping distributors informed of any test results, investigations or consumer feedback that may present a safety risk
Where safety risks or consumer incidents are identified, you must immediately notify your local Trading Standards service, who will work with you on next steps. It will be your responsibility to carry out any programme of corrective action or product recall.
If you fail to notify Trading Standards of any known issues or risks, you may be subject to enforcement action, which can lead to legal prosecution.
Under the Consumer Protection Act 1987, if any of your products are found to be unsafe, you could be sued by anyone affected – even if they didn’t buy the product themselves.
General guidance on placing goods on relevant markets is also available: