Product Regulatory Compliance
Most, if not all, of the UK legislation dealing with the safety of consumer products has its origins in a series of EU Directives, which have been implemented into UK law over the last twenty years or so. The most important and wide-ranging UK legislation is the General Product Safety Regulations 2005 (SI 2005/1803) (GPSR) and Part II of the Consumer Protection Act.
The GPSR apply to all products which are intended for consumers or are likely, under reasonably foreseeable conditions, to be used by consumers.
The GPSR do not apply where the product is subject to sector-specific safety regulations such as toys, food, tobacco, medical devices, medicines, vehicles and their parts etc., to the extent that the sector-specific legislation covers the same risks as the GPSR. The Brexit-related changes to sector-specific legislation are set out in the Product Safety and Metrology etc. (Amendment etc.) (EU Exit) Regulations 2019, which came into force on 1 January 2021. Where there is a crossover with the GPSR, the sector-specific safety legislation usually takes precedence.
A safe product is defined broadly as one which, under normal or reasonably foreseeable conditions of use, does not present any risk or only the minimum risks compatible with the product's use, considered to be acceptable and consistent with a high level of protection for the safety and health of persons.
Producers’ must not place any product on the market unless it is a safe product. From 1 January 2021, producers will include GB-based manufacturers, and UK-based importers of products regulated under the 2005 General Product Safety Regulations.
The General Product Safety Regulations 2005, define a “producer” as meaning:
- the manufacturer of a product, when they are established in the UK and any other person presenting themself as the manufacturer by affixing to the product their name, trademark or other distinctive mark, or the person who reconditions the product
- when the manufacturer is not established in the UK:
- if he has a representative established in the UK, the representative
- in any other case, the person established in the United Kingdom that places a product from a country outside the United Kingdom on the GB market; and
- other professionals in the supply chain, in so far as their activities may affect the safety properties of a product.
Up until 31st December 2020, CE marking, which is a European Union sign of product compliance for many products, was directly applicable to the United Kingdom, and manufacturers could only affix the CE marking when all of the requirements of applicable CE marking legislation had been met.
The new UK Conformity Assessed (UKCA) marking came into effect on 1st January 2021 as a result of the United Kingdom leaving the European Union. UKCA marking applies to most products previously subject to the CE marking. It also applies to aerosol products that previously required the ‘reverse epsilon’ marking.
In Northern Ireland, EU conformity markings continue to be used to show that goods meet EU rules. For most manufactured goods, this is the CE marking.
UKNI marking should be used (alongside the CE marking) if all of the following apply (i) certain goods are placed (mostly those goods subject to the CE marking) on the Northern Ireland market, (ii) those goods require mandatory third-party conformity assessment (iii) a mandatory third-party conformity assessment is carried out by an authorised UK body. UKNI marking cannot be used if either the goods are being placed on the market in the EU, or an EU body is used to carry out mandatory third-party conformity assessments. The UKNI marking is never applied on its own, it always accompanies an EU conformity marking, such as the CE marking.
The technical requirements and standards of the UKCA and UKNI are similar to those previously required for CE marking, and the circumstances in which a self-declaration of conformity can be used for UKCA and UKNI marking are the same as for CE marking.
UKCA marking is not recognised in the European Union, and products will still require CE marking for use in the European Union. To allow businesses time to adjust to the new requirements, it is permitted to use CE marking up until 1st January 2022 in most cases. UKCA marking does not apply to existing stock which was fully manufactured, CE marked and ready to place on the market before 1 January 2021. In this case, products can still be sold in Great Britain with a CE mark.
The are many potential pitfalls when introducing new products to market, including risks to consumers, inadequate safety instructions, or defects relating to product design or manufacturing processes, and claims for non-compliance may be brought in contract, tort or strict liability.
In Great Britain, local trading standards authorities have a duty to enforce the Regulations in relation to consumer goods. The 2005 Regulations also provide powers to the Secretary of State to enforce the Regulations. Any person committing an offence under the Regulations may be liable to a penalty. Penalties can include a fine of up to £20,000 or a prison sentence of up to 12 months or both for the most serious offences. The court may also forfeit any or all unsafe goods.
Andrew Skinner is an experienced regulatory trade lawyer (Solicitor) and has worked as an in-house lawyer for a global technology company, as well as in private practice. He is also a professionally qualified engineer and registered with the UK’s Engineering Council as a Chartered Engineer (CEng). Andrew advises clients on a range of trade compliance issues in various sectors, including electronics, aerospace & defence, cosmetics, IT, automotive, nuclear engineering and industrial engineering, delivering timely pragmatic advice in a way that recognises the commercial demands faced by clients.