Product certification is an important regulatory requirement of many businesses around the world to ensure the quality and performance of products. Many international regulations and contracts stipulate that products must be part of a certification scheme to ensure their quality. This also helps consumers know that the products they are purchasing are of high standards.
Due to the globalisation of commerce in the 21st century, your company or business must understand how product certification works in relation to your products. This article will outline key issues around product certification standards in the UK and Europe. It will also look at the impacts of Brexit on product certification and how to prepare for changing regulations in the years to come.
What are product certifications?
Product certifications are the processes by which a manufacturer ensures that products and services meet regulatory requirements as defined by individual countries. Countries and international organisations such as the European Union require product certification processes to be in place for certain products and services to assure adherence to environmental protection, health, and safety standards.
Part of the product certification process includes the physical affixing of product marking symbols onto products. This is the final step of the process that demonstrates the successful certification of a product. Different countries have different product markings, and sometimes multiple kinds of markings, such as the following examples:
- European Economic Area – Conformité Européenne (CE) Mark
- China – China Compulsory Certificate Mark
- Japan – Japanese Industrial Standards Mark
- Mexico – Norma Official Mexicana Mark
- Great Britain – UK Conformity Assessed Mark and Kitemark
- United States – Federal Communications Commission (FCC) Declaration of Conformity
- Australia and New Zealand – Regulatory Compliance Mark (RCM)
- International – International Fairtrade Cerfication Mark
These symbols demonstrate that appropriate processes have been followed by the manufacturer underSimple the relevant regulations of the destination market.
Why are product certifications important?
Product certifications are important because they ensure that companies and businesses adhere to national and international standards around certain goods. It is usually required in industries where the safety and quality of goods are of utmost importance. This provides assurance both to consumers against inferior quality goods and as well as protection to governments that maintain certain trade responsibilities under the law. Product certifications also ensure that companies and businesses are consistently considering the way their products can impact the health and safety of consumers in the ever-changing regulatory landscape.
Has Brexit impacted product certifications?
Brexit has greatly impacted product certification regimes. Whilst a member of the European Economic Area, the UK Government adhered to the European CE marking regime for goods on the market in the UK and for export to mainland Europe. After the UK public voted in favour of the withdrawal of the United Kingdom from the European Union in June 2016, trade with the remaining 27 European Union member nations has been one of the primary points of contention. As the EU has one of the strongest trade regulation schemes in the world, Britain’s planned exit from this scheme and negotiations towards compromises between the EU and UK Government have resulted in considerable debate over the past 5 years.
From 2016 to 2020, the UK Government and EU leaders negotiated the terms of the EU-UK Withdrawal Agreement to set out the terms of UK withdrawal from the European Union. Terms related to trade were of particular contention due to many factors such as product certification schemes and the complicating factor of the Northern Ireland Protocol – this was referred to in the media as the ‘Irish backstop’. The decision of this Protocol was for Northern Ireland to continue to adopt EU trade standards in the Single Market alongside the Republic of Ireland and other EU nations, whereas England, Scotland, and Wales will transition to UK standards.
The UK withdrew its membership from the European Union and the European Economic Area on 31 January 2020. The new UK rules on product certification were introduced on 1 January 2021. Businesses and companies in both the UK and EU will have a 1-year transition period to implement the new product certification regime for products sold in the UK. UK businesses and companies trading in the EU will still be required to carry the CE mark on required products. The new UKCA regime was fully implemented on 1 January 2022.
What product certifications are required in the UK?
From 1 January 2021, most products that require mandatory product certifications in Great Britain can use either UKCA or CE product certification processes. By 1 January 2022, most products that require mandatory product certification requirements in Great Britain will be legally mandated to use UKCA certification. There is a separate product certification regime in Northern Ireland as a result of the Northern Ireland Protocol of the EU-UK Withdrawal Agreement whereby manufacturers can use CE marking for self-assessed products and UK(NI) marking for products requiring third-party conformity assessments.
Which products require certification?
Under the CE and UKCA product marking regimes, similar products will require product marking. CE marking is mandatory for a broad range of products on the market in the EU. CE marking is not required for products sold in the EU such as foodstuffs, pharmaceuticals, cosmetics, and chemicals. The following categories of manufactured goods require CE marking:
- Active implantable medical devices
- Appliances burning gaseous fuels
- Cableway installations designed to carry persons
- Eco-design of energy-related products
- Electromagnetic compatibility
- Equipment and protective systems intended for use in potentially explosive atmospheres
- Explosives for civil uses
- Hot-water boilers
- Household refrigerators and freezers
- In-vitro diagnostic medical devices
- Low voltage
- Measuring instruments
- Medical devices
- Noise emission in the environment
- Non-automatic weighing instruments
- Personal protective equipment
- Pressure equipment
- Radio and telecommunications terminal equipment
- Recreational craft
- Safety of toys
- Simple pressure vessels
From 1 January 2022, UKCA product marking is required for products sold in Great Britain from the following categories of manufactured goods:
- Toy safety
- Recreational craft and personal watercraft
- Simple pressure vessels
- Electromagnetic compatibility
- Non-automatic weighing instruments
- Measuring instruments
- Radio equipment
- Pressure equipment
- Personal protective equipment
- Gas appliances
- Equipment for use outdoors
- Low voltage electrical equipment
- Restriction of hazardous substances
Some products sold in the UK such as medical devices, civil explosives, rail interoperability, and construction products will be covered by the UKCA marking regime but have special rules.
Is certification mandatory?
Product certification is mandatory for products in the UK and EU which have regulated specifications and require the addition of a marking. If EU businesses and companies do not go through the product certification process for goods that are required to adhere to certain standards, it will be illegal to trade these goods on the UK market. If British businesses and companies do not go through the product certification process for goods that are required to adhere to certain standards, it will be illegal to trade these goods in EU markets. If your business or company produces products that do not require product certification, you do not need to undertake a product certification process. Conversely, you are not permitted to apply a product mark on a non-mandatory product.
UKCA Mark Guide
United Kingdom Conformity Assessment (UKCA) marking is a new product certification marking used by importers and manufacturers who assert to consumers that their products conform to regulatory standards of England, Wales, and Scotland. Manufacturers seeking to place certain goods on the market in Northern Ireland will follow different standards as outlined by the Nothern Ireland Protocol and use either the CE mark or a new UK(NI) mark.
Due to the UK departure from the EEA single market, the UK Government has chosen an alternative product marking to distinguish its trade rules from that of the EEA. Since 1 January 2021, the UKCA marking has been in place for some goods that previously required the European Economic Area (EEA) CE product marking. For companies trading most products, there is a grace period until 1 January 2022 during which time the CE mark can be phased out and the UKCA mark can be phased into business. After 1 January 2022, specified products placed on the UK market will require UKCA marking. Due to Brexit, the CE mark will not be recognised as an alternative marking in Great Britain. EEA products being sold to English, Scottish, and Welsh markets will require UKCA marking after the end of the grace period on 1 January 2022.
Only those manufacturers whose goods meet the following criteria will be required to start using the new UKCA marking before 1 January 2022:
- Your goods are on the market in Great Britain (England, Scotland, and Wales)
- Your goods are included in legislation that stipulates the requirement of a UKCA mark
- Your goods fall under a product category that requires a mandatory third-party conformity assessment process
- Your goods require assessment by a UK conformity assessment body
To apply for a UKCA mark, you must follow a strict regulatory process. Under British law, manufacturers are the responsible parties for ensuring that products they produce will meet all UK environmental protection, health, and safety standards. To obtain UKCA marking and legally trade in Great Britain, product manufacturers must follow a 4 step regulatory process.
You must ensure that your product is in line with all UK legislative requirements relevant to the product category. This will differ depending on the kind of product you make.
You must determine if you will be required to undertake a third-party conformity assessment by a regulated UK conformity assessment body or if you can undertake a self-declaration of conformity for your product. UKCA marking can be implemented in two different ways, depending on the category of the product. Some products will require manufacturers to go through an examination process through a UK-approved standards body such as the British Standards Institution. This approved body will test the quality and performance of the product to ensure it complies with UK legislation. Other products will allow manufacturers to self-declare the quality and performance of their goods in line with British law without the need to submit to an examination process. You should consult the relevant legislation to determine the specific applicability of self-declaration for goods. Self-declaration is allowed for products that fall under the following legislative areas:
- Electromagnetic Compatibility Regulations – All products
- Toy (Safety) Regulations – Some products
- The Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment Regulations 2012 – All products
- Medical Devices Regulations 2002 – Some Class I products
- Radio Equipment Regulations 2017 – Some products
- The Pressure Equipment (Safety) Regulations 2016 – Category I products
- Construction Products Regulations – Some System 4 products
- Recreational Craft Regulations 2017 – Some products
- The Electrical Equipment (Safety) Regulations 2016 – All products
- The Supply of Machinery (Safety) Regulations 2008 – Some products
- The Equipment and Protective Systems Intended for Use in Potentially Explosive Atmospheres Regulations 2016 – Some products
- Personal Protective Equipment Regulations – Category I products
Once you have determined which route is applicable for your goods, you must undertake the third-party conformity assessment or self-declaration assessment. If you are permitted to conduct a self-declaration assessment this process will be free. If you are required to have an independent assessment of your products, this price will drastically vary depending upon factors such as relevant regulations to your product and the number of products your company or business produces. You can contact an individual third-party conformity assessor to determine specific costs for your product assessment.
You must collect the relevant technical documentation related to your product and its certification process and keep it on file at all times for 10 years after the product goes to market. You should keep this documentation on file in case it is ever requested by a market surveillance authority. The specific documentation required will depend upon legislative requirements.
You must attach the UKCA mark to your product and draft the UK Declaration of Conformity document concerning your product.
The UKCA marking process will generally take 4 to 8 weeks from start to finish so you should ensure plenty of time for this vital step before placing goods on the market in England, Scotland, and Wales. This process is liable to change due to in the UK, so you should be sure to keep up-to-date on trade developments in Great Britain.
CE Mark Guide
Conformité Européenne (CE) marking is a product marking used by importers and manufacturers who assert to consumers that their products conform to standards of the European Union. These markings relate to environmental protection, health, and safety standards required within the EEA Market as required by relevant European Directives and Regulations. Specified products manufactured anywhere in the world that are sold in the EU will require a CE mark. Regardless of changes due to Brexit, the UKCA mark will not be recognised in the EEA, so specified British products being sold to the EEA market will require CE marking.
Under EU law, manufacturers are the responsible parties for ensuring that products they produce will meet all EU environmental protection, health, and safety standards. To obtain CE marking and legally trade on the European Single Market, product manufacturers must follow a 6 step regulatory process.
You must ensure that your product is in line with all EU requirements relevant to the product category. This will differ depending on the kind of product you make.
You must determine the specific requirements for your product. This will differ depending on the kind of product you make.
You must determine if you will be required to undertake an assessment by a notified body or if you can undertake a self-assessment of the product. CE marking can be implemented in two different ways, depending on the category of the product. Some products will require manufacturers to go through independent assessment through an EU-approved notified body. This approved body will test the quality and performance of the product to ensure it complies with EU legislation. Other products will allow manufacturers to self-assess the quality and performance of their goods in line with EU law without the need to submit to an examination process. You should consult the relevant legislation for your industry to determine the specific applicability of self-declaration for goods. The vast majority of products are eligible for self-assessment certification.
You must undertake the self-assessment or independent assessment. If you are permitted to conduct a self-assessment, this process will be free. If you are required to have an independent assessment of your products, this price will drastically vary between £70 to £73,000 depending on the type and market price of your product.
You must collect the relevant technical documentation related to your product and its certification process and keep it on file at all times.
You must attach the CE mark to your product and draft the EU Declaration of Conformity document concerning your product.
The CE marking process will generally take 4 to 6 weeks from start to finish so you should ensure plenty of time for this vital step before placing goods on the EEA market.
UKCA & CE Product Certification FAQs
Do I need a UKCA mark?
You will need a UKCA mark for your products starting from 1 January 2022 for most specified products being sold in England, Scotland, and Wales. Generally, this will apply to products that required CE marking before 1 January 2021. Some products such as certain medical devices will have an extended transition period from the CE marking to the UKCA marking until 2023.
How do I get a UKCA mark?
You can get a UKCA mark for your product by following a 4 step process. You will need to: 1) research the relevant legislation and regulatory requirements for your product, 2) undertake either a third-party conformity assessment or self-declaration assessment, depending on regulatory requirements for your product, 3) collect relevant technical documentation, and 4) affix the UKCA mark on your product and draft the UK Declaration of Conformity documentation.
How do I get a CE certification?
You can get a CE certification for your product by following a 6 step process. You will need to 1) research the relevant legislation for your product, 2) determine specific regulatory requirements for your product, 3) determine if you will be required to undertake an assessment by a notified body or if you can undertake a self-assessment of the product, 4) undertake the relevant assessment for your product, 5) collect relevant technical documentation, and 6) affix the CE mark on your product and draft the EU Declaration of Conformity documentation.
What happens to CE marking after Brexit?
Since the UK withdrawal from the European Union Customs Union on 31 December 2020, the UK has begun a transition process away from the use of the CE marking. The use of the UKCA marking became mandatory for most specified products on the market in England, Scotland, and Wales on 1 January 2022. Some products such as certain medical devices will have an extended transition period from the CE marking to the UKCA marking until 2023. The CE marking will continue to be used for British imports destined for the EU and some imports to Northern Ireland.
The matters contained in this article are intended to be for general information purposes only. This article does not constitute legal advice, nor is it a complete or authoritative statement of the law, and should not be treated as such. Whilst every effort is made to ensure that the information is correct, no warranty, express or implied, is given as to its accuracy and no liability is accepted for any error or omission. Before acting on any of the information contained herein, expert legal advice should be sought.