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BRIEFING PAPER
Number 8583, 12 September 2019
Brexit: product standards and safety marking
By Lorraine Conway
Contents: 1. Introduction to product
standards 2. EU New Legislative
Framework 3. Operation of EU product
safety regime 4. No-deal Brexit: impact on
product safety regime 5. No deal Brexit: what it means
for manufacturers
2 Brexit: product standards and safety marking
Contents Summary 3
1. Introduction to product standards 5 1.1 What are standards? 5 1.2 Examples of standards 6 1.3 Why use standards? 6 1.4 Difference between a standard and a technical regulation 7 1.5 National, international and European standards 8
National standards 8 International standards 8 European standards 8
1.6 What is conformity assessment? 11
2. EU New Legislative Framework 12 2.1 Background 12 2.2 Key features of the NLF 14 2.3 EU legislation and reference to standards 16
3. Operation of EU product safety regime 18 3.1 Non-harmonised goods 18 3.2 Harmonised goods 19 3.3 CE Marking 19 3.4 The General Product Safety Directive 20
4. No-deal Brexit: impact on product safety regime 22 4.1 European Commission Notice 22 4.2 BSI continued membership of CEN & CENELEC 23 4.3 The Product Safety and Metrology (Amendment etc.) (EU Exit)
Regulations 25 4.4 New UKCA mark 26
5. No deal Brexit: what it means for manufacturers 28 5.1 Overview 28 5.2 Placing products on the UK market after a no-deal Brexit 29 5.3 Placing products on the EU market after a no-deal Brexit 30
Cover page image copyright attribution: Factory warehouse / image cropped. Licensed under Pixabay License – no copyright required.
3 Commons Library Briefing, 12 September 2019
Summary At the outset, an important distinction needs to be made: standards are not the same as regulation. While conformity with standards is voluntary, regulations are by nature mandatory. Standards may describe good business practices, set out guidance, or document technical specifications. They are usually developed through a consensus process by industry experts and other stakeholders likely to be affected by the standards. They are maintained for as long as the market needs them.
The stated aim of the EU’s New Legislative Framework is to provide a means for business and industry to trade more easily within the European Single Market. This is achieved in three ways:
• through mutual recognition of national requirements;
• through EU regulatory harmonisation; and
• through European standardisation.
Important to the operation of the Single Market, for industry and consumers, are standards and a set of single, or mutually recognised, legal requirements.
Approximately 25 per cent of European standards are developed following a European Commission request, and support EU legislation and public policy. Most of these standards specifically respond to harmonised regulatory requirements across the Single Market. The Single Standard Model means that, where standards are used in this way by policy makers, only one standard is needed to meet a specific aspect of regulation. Such standards are known as “harmonised standards” (“hEN”). Where an individual standard is identified and referenced as a means of compliance, the use of this standard is voluntary. Manufacturers and other economic operators can, if they wish, use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation, but they are also free to choose another technical solution to demonstrate compliance. Ultimately, responsibility for complying with the requirements of the regulation rests with the supplier of the goods or service.
On Brexit day, future UK influence over the European standardisation system would depend largely on a range of political choices to be made by the Government. A key question being whether the UK continues to commit to the adoption of European standards and the withdrawal of conflicting national standards.
The May Government’s position has been to call for a comprehensive system of mutual recognition and a commitment to maintain UK regulatory standards in line with the EU’s. At the same time, preparations are taking place across government to ensure that in the case that the UK leaves the EU without a deal, regulatory continuity will be ensured. This includes both the designation of standards to support regulations under the New Legislative Framework and the introduction of a new UK regulatory mark that will be affixed to products or their packaging.
4 Brexit: product standards and safety marking
This Commons briefing paper considers the UK’s conformity with EU product standards and safety marking in the lead up to Brexit. In the process, it provides an outline of the EU’s New Legislative Framework. It also considers the UK’s position in the event of a “No Deal” Brexit, including the BSI’s (British Standards Institute) continued membership of CEN and CENELEC (European Standardisation Organisations); the provisions of the Product Safety and Metrology (Amendment etc.) (EU Exit) Regulations; and the possible impact on consumers and businesses.
5 Commons Library Briefing, 12 September 2019
1. Introduction to product standards
1.1 What are standards?
Box 1: What are standards?
• Standards are technical specifications defining requirements for products, production processes, services or test-methods. These specifications are voluntary.
• They are developed by industry following some basic principles such as consensus, openness, transparency and non-discrimination.
• Standards ensure interoperability1 and safety, reduce costs and facilitate companies' integration in a market.
• There are national, international and European standards.
Simply put, a standard is an agreed way of doing, thinking about or managing something. The International Organization for Standardization (ISO), defines a standard as:
“a document that provides requirements, specifications, guidelines or characteristics that can be used consistently to ensure that materials, products, processes and services are fit for their purpose. Standards can relate to anything, including definitions and classifications, manufacturing, process management or service delivery.”2
Basically, standards include requirements and/or recommendations in relation to products, systems, processes or services. They can also be a way to describe a measurement or test method or to establish a common terminology within a specific sector. They may set out guidance or document technical specifications.
According to the BSI (the British Standards Institution, the national standards body of the UK), the development of standards is often driven by a demand from industry:
Standards help to solve fundamental process, organisational and technical problems, which if left unresolved, could result in inefficient market functioning and poor economic outcomes.
[…]
standards play a direct or indirect role in the productivity and efficiency of companies – through reducing the cost of producing goods and services, increasing revenue by opening up new markets, or boosting the efficiency with which goods and services are produced. Standards can serve many purposes and therefore solve multiple issues.3
1 “Interoperability” is a characteristic of a product or system, whose interfaces are
completely understood, to work with other products or systems, at present or in the future, in either implementation or access, without any restrictions.
2 International Organization for Standardization (ISO), “Teaching Standards”, 2014, page 7, [online] (accessed 12 September 2019)
3 “The Economic contribution of standards to the UK economy”, Centre for Economics and Business Research (CEBR) commissioned by the British Standards Institution (BSI), June 2015, pages 17-18, [online] (accessed 12 September 2019)
6 Brexit: product standards and safety marking
Product standards can bring benefits to businesses and consumers in terms of reducing costs, enhancing performance and improving safety. Standards can also facilitate international trade by ensuring compatibility and interoperability4 of components, products and services.
1.2 Examples of standards There are many different types of standards covering a wide variety of activities undertaken by businesses in the production of their products or services and in supplying their customers. Examples include:
• a quality management standard to help an organisation work more efficiently and reduce product failures (e.g. Quality Management ISO 9001);
• an environmental management standard to help reduce environmental impacts, reduce waste and be more sustainable (e.g. ISO 14001 Environmental Management);
• a health and safety standard to help reduce accidents in the workplace (e.g. ISO 45001 Occupational Health and Safety Management); and
• an IT security standard to help keep sensitive information secure (e.g. ISO/IEC 27001 Information Security Management (ISMS).
Other examples might include standards concerned with construction; energy management; food safety; and improving the accessibility of buildings for disabled users.5
1.3 Why use standards? On the Gov.UK website, standards are described as providing a reliable basis for people - businesses and consumers - to share the same expectations about a product or service. This helps to:
• facilitate trade;
• provide a framework for achieving economies, efficiencies and interoperability;6
• enhance consumer protection and confidence.
Standards can be supported through measurement, testing, certification, and accreditation.
Standards are also an important factor in support of government objectives, for example:
• competitiveness;
• fair trading;
• protection of consumer interests, the environment and sustainability; and
4 Ibid 5 BSI “What is a standard?”, undated, [online] (accessed 12 September 2019) 6 For a definition of “interoperability” see footnote 1
7 Commons Library Briefing, 12 September 2019
• regulatory compliance
On the same website, the Department for Business, Energy and Industrial Strategy (BEIS) states that standards can support and promote innovation. The relevant extract is reproduced below:
[Standards] …create a common framework that encourages the sharing of knowledge. This reduces the need for duplication during research and development. Standards contribute to productivity because they:
• increase efficiency by improving processes;
• reduce cost by minimising waste and cutting out the time spent on “trial and error”;
• allow production at scale by replacing bespoke variety with standardised solutions, performance or outcomes; this frees up resources for differentiating products and services from those of competitors;
• lower the cost of regulatory compliance and the costs of non-compliance
• shorten the time to market new products
Standardisation provides a competitive edge in the market place. In particular for small and medium-sized businesses, as proving compliance with an accepted standard can replace the power of a big brand.7
1.4 Difference between a standard and a technical regulation
Standards are not the same as regulation. In simple terms, the difference between a standard and a technical regulation lies in compliance. While conformity with standards is voluntary, regulations are by nature mandatory. The BSI provides the following useful explanation:
The relationship between standards and regulations is frequently confused. Standards can assist companies to comply with legislation but in almost all cases in the EU and EFTA countries are not a legal obligation.8 While standards provide a straight forward way to demonstrate conformity, with very few exceptions their use is voluntary – it is up to the individual company to decide whether to try and meet the requirements of the legislation themselves or to adopt the standard. Some standards may become a market requirement, as has happened in the case of EU construction products regulation.9
7 Department for Business, Energy and Industrial Strategy, “Guidance:
Standardisation”, 11 December 2012, Gov.UK website, (accessed 12 September 2019)
8 In the EU, the voluntary ‘New Approach’ system of technical harmonisation introduced in 1985 specifies standards as one means of conformity with the ‘essential requirements’ of European directives. Where another technology/method is used to meet the essential requirements, or in the absence of standards, the burden of proof that the product meets the essential requirements rests on the producer or importer of the product.
9 A rare example where standards are mandatory is in the construction products industry, where the 2011 EU Construction Products Regulation has made it a
Standards are generally voluntary which means that there is no automatic legal obligation to apply them. However, standards may help businesses show compliance with legislation.
8 Brexit: product standards and safety marking
Around a quarter of European standards are associated with EU legislation and other public policy. (see below).10
1.5 National, international and European standards
As already mentioned, standards play an important role in facilitating international commerce by reducing technical barriers to trade. Harmonisation of standards across countries can act as a major driver for trade – allowing companies to sell their products and services without the need for adaptations across multiple markets
National standards In the UK, the BSI is appointed by the UK government as the organisation responsible for developing and publishing British Standards. According to its website, the BSI facilitates collaboration between industry experts, government bodies, companies, academia, trade associations and consumer groups. Each standard is developed to represent an industry-wide consensus on best practice.
The BSI also participates in the development of international and European standards, the majority of which are also adopted as British standards.
International standards The BSI participates in international standards development via its membership of the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC). All countries that are signatories to the World Trade Organisation (WTO) Technical Barriers to Trade Agreement 1995 have a national standards body who participates in the development and adoption of new international standards and the publication of standards in their country. In a nutshell, the Agreement seeks to avoid unnecessary barriers by setting out a code of good practice, whereby countries recognise and use international standards as the basis for technical regulations.
European standards Generally speaking, products offered for sale in the Single Market either fall:
• within a non-harmonised sector, where national legislation and mutual recognition applies, or
• within a harmonised sector, where standards are used in a variety of ways to support EU legislation.11
Harmonisation can take several forms: it can be minimum harmonisation or one of several types of total harmonisation (see Section 2 below).
mandatory requirement that products are manufactured to a common European technical specification (EN standards).
10 British Standards Institution (BSI), “European Standards and the UK”, undated, p.6, [online] (accessed 12 September 2019)
11 Ibid
9 Commons Library Briefing, 12 September 2019
All European standards respond to the needs of the Single Market. Governance of European standards is the responsibility of the following European Standardisation Organisations (ESOs):
• CEN (the European Committee for Standardization);
• CENELEC (the European Committee for Electrotechnical Standardization); and
• ETSI (the European Telecommunications Institute).
The ESOs are the only organisations authorised to create European standards. Each body is recognised as competent in an area of voluntary technical standardisation pursuant to EU Regulation 1025/2012 (see below). European Standard (ENs) documents are ratified by one of the three Organisations.
The UK’s BSI participates in European standards development via its membership of these organisations.12 Specifically, membership of CEN and CENELEC comprises the National Standards Bodies (NSBs) of all the Member States of the EU and other countries that are part of the European Single Market. It is a condition of both CEN and CENELEC that all European standards are adopted identically by all members.
EU Regulation 1025/2012 provides a legal basis to:
• use European standards for products and services;
• identify ICT technical specifications; and
• finance the European standardisation process.
Under this Regulation, the development of new national standards must be reported to the ESOs at least annually by each NSB (i.e. by the BSI in the UK), to provide transparency on national programmes. Importantly, once a European standard is published, each CEN and CENELEC member country is required to implement the European standard as a national standard and withdraw any pre-existing standards that conflict with the new European standard.
It is estimated that around 25 per cent of European standards are developed following a European Commission request, and support EU legislation and public policy.13 The majority of these standards, specifically respond to harmonised regulatory requirements across the Single Market. The Single Standard Model means that, where standards are used in this way by policy makers, only one standard is needed to meet a specific aspect of regulation. Such standards are known as “harmonised standards” (“hEN”). They provide one means of meeting the regulatory requirement while remaining voluntary.
This is a crucial point. Under the New Legislative Framework (see Section 2 below), where individual standards are specifically identified, they are referenced only as a means of compliance - their use is usually voluntary. What this means in practice is that manufacturers, other 12 The UK currently has just over 7 per cent of votes at the main stages of the
development process of each CEN and CENELEC standard. 13 British Standards Institution (BSI), “European Standards and the UK”, undated, p.6,
[online] (accessed 12 September 2019)
Single Standards Model underpins the Single Market
Harmonised European standards
Withdrawal of conflicting national standards.
10 Brexit: product standards and safety marking
economic operators, or conformity assessment bodies can, if they wish, use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation. They are also free to choose another technical solution to demonstrate compliance with mandatory legal requirements (see Box 2 below).
Box 2: Harmonised European standard
• A harmonised standard is a European standard developed by a recognised European Standards Organisation (CEN, CENELEC, or ETSI). It is created following a request from the European Commission to one of these organisations.
• The references of harmonised standards must be published in the Official Journal of the European Union (OJEU). An EU website provides access to the latest list of references of harmonised standards and other European standards published in the OJEU.
• The use of harmonised standards remains voluntary. Manufacturers, other economic operators, or conformity assessment bodies can use harmonised standards to demonstrate that products, services, or processes comply with relevant EU legislation. However, they are free to choose another technical solution to demonstrate compliance with mandatory legal requirements.
The 75 per cent of European standards that are not developed following a European Commission request (mandate) meet other market needs. They include: test methods, terminologies, specifications for products and services, business process standards and guidance on good practice.14
Finally, it is worth mentioning that in the UK a key driver of the growth in the BSI standards catalogue over the past 25 years has been the increasing internationalisation of standards, at the EU level and beyond. The BSI explains the position as follows:
[…] before the 1990s, almost all standards within the BSI Catalogue originated in the UK. EU harmonisation of standards led to the wide-scale adoption of European standards within the UK catalogue.
At the same time the 1991 Vienna Agreement, which formalised technical cooperation between ISO and CEN, and the parallel Dresden Agreement between IEC and CENELEC in 1996 were signed with the aim of minimising overlap in standards by developing single common standards at international and European level. These agreements resulted in the automatic adoption of many international standards into the BSI catalogue, as they were also European standards.
Standards that would previously have been developed solely for UK companies have been replaced by common European standards (some of which are also international standards). Other international standards developed via ISO and IEC are also overwhelmingly adopted as British standards. This has resulted in
14 Ibid
11 Commons Library Briefing, 12 September 2019
a staggering drop in the share of British-only standards from 88% in 1990 to 2%15 in 2014.16
1.6 What is conformity assessment?
Box 3: Conformity assessment?
This is the process by which persons can legally place safe and compliant products onto the European market (or bring them into use) for the first time. Conformity assessment is a common feature of the New Approach Directives (see Section 2 of this paper below) concerned with product safety, and includes various checks on the:
• design and construction of products to meet essential requirements which normally are for health and safety;
• and being able to demonstrate this through a technical file before declaring and certifying a products' conformity with all relevant Directives, and affixing CE marking to the product. Some products can be self-certified through this process, but others must undergo specific conformity assessment procedures involving third parties known as Notified or Conformity Assessment Bodies, before the manufacture can declare conformity.
As outlined in Box 3, conformity assessment is an important way to give confidence in goods, services and management systems; it provides assurance that what is being supplied meets the expectations specified or claimed. Conformity assessment can be applied to: products; services; processes; systems and bodies. It includes assessment activities such as testing, inspection and certification. These checks are carried out by conformity assessment bodies. Each EU Member State is required to appoint a single national accreditation body to carry out the accreditation of conformity assessment bodies.
In the UK, BEIS is responsible for conformity assessment and accreditation policy. The UK Accreditation Service (UKAS) is appointed by BEIS to be the national accreditation body.17
15 This percentage is low, but the UK contributes to CEN/ CENELEC technical
committees, with 293 working group convenors coming from UK committees in 2013. Many standards adopted at EU level have their origins in standards developed by BSI technical committees for UK companies.
16 “The Economic contribution of standards to the UK economy”, Centre for Economics and Business Research (CEBR) commissioned by the British Standards Institution (BSI), June 2015, page 31, [online] (accessed 12 September 2019)
17 UKAS is appointed as the national accreditation body by Accreditation Regulations 2009 (SI No 3155/2009 and EU Regulation (EC) 765/2008 and operates under a Memorandum of Understanding with the Government through the Secretary of State for BEIS.
12 Brexit: product standards and safety marking
2. EU New Legislative Framework I should state at the outset that any discussion of the EU New Legislative Framework (NLF) is highly technical in nature.
Since 2008, the NLF has been the cornerstone of Internal Market legislation. It brings together all the different elements that need to be dealt with in product safety legislation. The NLF can be used in all industrial sectors, whenever EU legislation is required.
2.1 Background
Box 4: Four phases of EU legislation on the free movement of goods
Historically, EU legislation on the free movement of goods has progressed through four main phases18, namely:
• The traditional approach or Old Approach with detailed texts containing all the necessary technical and administrative requirements.
• The New Approach developed in 1985, which restricted the content of legislation to “essential requirements” leaving the technical details to European harmonised standards. This in turn led to the development of European standardisation policy to support this legislation.
• The development of the conformity assessment instruments made necessary by the implementation of the various EU harmonisation acts, both New Approach and Old Approach.
• The New Legislative Framework adopted in July 2008, which built on the New Approach and completed the overall legislative framework with all the necessary elements for effective conformity assessment, accreditation and market surveillance including the control of products from outside the EU.
As outlined in Box 4, the “New Approach” to technical harmonisation and standards, introduced in 1987, was a key part of the development of the Single Market, in that it removed technical barriers to trade. Specifically, the approach was to restrict the content of legislation to “essential requirements” leaving technical details to European Harmonised Standards. In terms of conformity assessment, in 1989 and 1990 the Council adopted a Resolution on the Global Approach and Decision 90/683/EEC which laid down general guidelines and detailed procedures.19
However, following a consultation in 2002 and a review into the functioning of the internal market for goods in 2006, the European Commission concluded that the EU harmonised legislation was not as effective as it should be. On 7 May 2003, there was a Communication from the European Commission to the Council and the European Parliament suggesting a possible revision of certain New Approach 18 “European Commission Notice, “The ‘Blue Guide’ on the Implementation of EU
Products Rules 2016”, OJEU 2016/C272/01, vol. 59, 25 July 2016, [online] (accessed 12 September 2019)
19 Ibid
13 Commons Library Briefing, 12 September 2019
elements, “Enhancing the implementation of the New Approach Directives”.20 The European Council’s Resolution on this communication was made on 10 November 2003.21 A Regulation and a Decision (constituting part of the “Ayral Goods Package”) were subsequently adopted by the European Parliament and the Council on 9 July 2008.22 The “New Legislative Framework” (NLF) came into force on 1 January 2010.
The NLF consists of:
• Regulation (EC) No 765/2008 setting out the legal basis for accreditation and market surveillance of products (and consolidating the meaning of CE marking).
• Decision No 768/2008/EC establishing a common framework for the marketing of products (a template for future product harmonisation legislation).
• Regulation (EC) No 764/2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another EU country. (In other words, the aim of the Regulation is to strengthen the internal market for a wide range of other products not subject to EU harmonisation).
In a nutshell, the NLF establishes a common set of principles to make legislation on the Single Market for goods clearer, more consistent and more understandable. It aims to:
• improve market surveillance rules to better protect both consumers and professionals from unsafe products, including those imported from outside the EU;
• boost the quality of and confidence in the conformity assessment of products by setting clear, transparent rules for the accreditation of conformity assessment bodies;
• clarify the meaning and use of CE marking and enhance its credibility; and
• establish a common legal framework for industrial products in the form of a ‘toolbox’ of measures for use in future legislation. (This includes definitions of terms commonly used in product legislation, and procedures to allow future sectorial legislation to become more consistent and easier to implement).
In February 2014, an “Alignment Package” was introduced to align 9 existing EU Directives to the NLF. These were:
• Civil Explosives 2014/28 EU
• Simple Pressure Vessels 2014/29 EU
• Electromagnetic Compatibility 2014/30 EU
• Non-Automatic Weighing Instruments 2014/31 EU
• Measuring Instruments 2014/32 EU
20 COM (2003) 240 21 OJC282, 25.11.2003, p3 22 OJL218, 18.8.2008
What does the NLF consist of?
Nine New Approach Directives aligned to the NLF.
14 Brexit: product standards and safety marking
• Lifts and their Safety Components 2014/33 EU
• Equipment for Use in Explosive Atmospheres (“ATEX”) 2014/34 EU
• Low Voltage 2014/35 EU
• Pyrotechnic Articles 2013/29 EU
This package of directives had to be transposed by Member States into their national law by April 2016. Legislation aligned with the NLF has also been adopted in other areas, including:
• Toy Safety - Directive 2009/48/EU
• Restriction of Hazardous Substances in Electrical and Electronic Equipment - Directive 2011/65/EU
• Construction products - Regulation (EU) No 305/2011
• Pyrotechnic Articles - Directive 2013/29/EU
• Medical devices - Regulation (EU) 2017/745
The European Commission has explained the position as follows:
The objectives of the first harmonisation directives focused on the elimination of barriers and on the free movement of goods in the single market. These objectives are now being complemented by a comprehensive policy geared to ensuring that only safe and otherwise compliant products find their way on to the market, in such a way that honest economic operators can benefit from a level playing field, thus promoting at the same time an effective protection of EU consumers and professional users and a competitive single EU market.23
It should be evident that a great many of the safety-orientated harmonised measures for manufactured products fall under the NLF, but some, notably motor vehicles and medicines, do not. Food and agricultural products have quite separate legal regimes.
2.2 Key features of the NLF The following important points about the NLF should be noted:
• Its main objective is to make product harmonisation legislation consistent. Decision 768/2008/EC is now the template for product harmonisation legislation. Its provisions are being incorporated into existing Directives when they are revised.
• A key feature of the NLF is the use of “reference to standards”. The mandatory measures make use of voluntary standards (see below).
• It considers all the economic operators in the supply chain – manufacturers, distributors and importers - and their respective roles in relation to the product. The importer has clear obligations in relation to the compliance of products, and where a distributor or an importer modifies a product or markets it under their own
23 “European Commission Notice, “The ‘Blue Guide’ on the Implementation of EU
Products Rules 2016”, OJEU 2016/C272/01, vol. 59, 25 July 2016, [online] (accessed 12 September 2019)
What does the NLF provide?
A key feature of the NLF is its use of “reference to standards.”
15 Commons Library Briefing, 12 September 2019
name, they become the equivalent of the manufacturer and must take on the latter's responsibilities in relation to the product.
• Under the NLF, compliance is assessed with regard to the legal requirements applicable at the time of “the first making available”.
• It recognises the different facets of the responsibilities of the national authorities: the regulatory authorities, the notification authorities, those which oversee the national accreditation body, the market surveillance authorities, the authorities responsible for the control of products from third countries, etc., underlining that responsibilities depend on the activities carried out.
• It introduces a comprehensive policy on market surveillance.24 It emphasises enforcement aspects during the whole life-cycle of products.
A key priority of the NLF is to strengthen what is still commonly known as the New Approach to technical harmonisation and standards, (it is still referred to in this way even though it was expanded and updated in 2008 into the NLF). Under this approach, individual standards are specifically identified and referenced as a means of compliance, but their use is voluntary. The supplier is free to choose another technical solution to demonstrate compliance with the relevant EU legislation.
In other words, the NLF recognises that standards are “a voluntary, end-user-driven and private compliance tool” and adopts an approach that “aims to give flexibility to producers while reducing administrative burdens”.25 Further detailed information is set out below (sections 2.2 and 2.3).
24 On 13 February 2013, the European Commission adopted a proposal for a new stand-
alone Market Surveillance Regulation (COM (2013)75 final), bringing together all market surveillance provisions from Regulation (EC) No 765/2008, the General Product Safety Directive, and sectoral legislation.
25 “European Commission Notice, “The ‘Blue Guide’ on the Implementation of EU Products Rules 2016”, OJEU 2016/C272/01, vol. 59, 25 July 2016, [online] (accessed 12 September 2019)
16 Brexit: product standards and safety marking
2.3 EU legislation and reference to standards
Box 5: EU legislation
In brief, EU legislation may take the form of:
• A regulation, which is used to implement objectives under EU law. Unlike directives, which are passed at EU level and then implemented at national level, once an EU regulation is passed at EU level it has direct effect in every EU Member State at the same time. Regulations are commonly used to implement EU law, for example, to ensure common safeguards on goods imported from outside the EU, the Council adopted a regulation.26 A directive is a form of legislation that is “directed” at the Member States. It sets out an objective that all EU countries must achieve. Each Member State must pass the relevant domestic legislation to give effect to the terms of the Directive within a time frame set in the directive, usually two years (for example, the Consumer Rights Act 2015 implements in the UK the Consumer Rights Directive (2011/83/EU)). There are NLF directives on a wide range of goods and services, including: toys; electrical equipment; pyrotechnics; measuring instruments; and medical devices.
The relationship between standardisation and EU legislation (see Box 5 above) has been developed in accordance with the so-called “New Approach” to technical harmonisation and standards as expanded and updated in 2008 into the NLF. In summary:
• The EU adopts legislation (EU directives) that defines essential requirements – in relation to safety and other aspects of public interest – which must be met by products and services being offered for sale in the Single Market.
• The European Commission issues standardisation requests (i.e. mandates) to the ESOs (CEN, CENELEC and ETSI).27
• Member States must recognise that all products manufactured (and services provided) in accordance with harmonised standards are presumed to conform to the essential requirements as defined by the relevant EU legislation.
• However, European standards remain voluntary and there is no legal obligation to apply them. Any producer (or service provider) who chooses not to follow a harmonised standard is obliged to prove that their products (or services) conform to the essential requirements.
There are two crucial points to note:
I. First, since the NLF entails harmonisation legislation,28 Member States can only introduce more stringent provisions on an exceptional basis and only when they will not prejudice the harmonisation, or where they are justified because of environmental or workplace needs, or in line with Article 36 of the Treaty for the Functioning of the European Union (TFEU).
26 In the UK, EU Regulations apply by virtue of the European Communities Act 1972 27 As stated in Section 1 of this Paper, approximately 25% of European standards
published by CEN have been developed in response to standardisation requests (or mandates) issued by the European Commission
28 Created under Article 114 of the Treaty for the Functioning of the European Union
17 Commons Library Briefing, 12 September 2019
II. Second, when businesses make use of harmonised standards, they benefit from a “presumption of conformity” with the requirements set out in the relevant EU legislation.
The BSI has explained the workings of the NLF, from a standards perspective, as follows:
“[..] the key to the NLF is that the legislator separates the high level ‘essential’ requirements from the technical specifications needed to manufacture the products. Legislation covers only those essential requirements and the precise means of meeting those requirements is left to the market. One way to meet the requirements – which is voluntary – is by applying harmonised standards.
[…]
Compliance with such standards, once their references have been published in the EU’s Official Journal, confers a presumption of conformity with applicable law. This harmonisation legislation and the use of harmonised standards is the main area where standards are used to support legislation. Around 4,000 hENs serve this purpose”.29
29 British Standards Institution (BSI), “European Standards and the UK”, undated,
[online] (accessed 12 September 2019)
18 Brexit: product standards and safety marking
3. Operation of EU product safety regime
To recap from the previous section, the NLF is a framework of general principles and rules, which aims to make legislation on the Single Market for goods clearer, more consistent and more effective.
Many products on the EU market are subject to harmonised rules designed to protect consumers, public health, and environment. Harmonised rules preclude the adoption of possibly divergent national rules and ensure the free circulation of products within the EU.
However, some sectors are still governed by national provisions and circulate their products within the EU under the Mutual Recognition Principle.
Further detailed information is set out below.
3.1 Non-harmonised goods To ensure the free movement of goods in non-harmonised sectors, the Principal of Mutual Recognition, the 2015/1535 notification procedure, and the application of Arts. 34-36 TFEU are essential.
The Mutual Recognition Principle ensures market access for products that are not subject to EU harmonisation (for example, textiles, furniture and bicycles).30 It ensures that a product lawfully sold in one EU country can be sold in another. This is possible even if the product does not fully comply with the technical rules of the other country. The right of an EU Member State to deny market access for a product lawfully marketed in another Member State is limited to concerns regarding public safety, policy and morality.
Importantly, a new regulation on the mutual recognition of goods will apply in the EU as of 19 April 2020. Regulation (EU) 2019/515 on the mutual recognition of goods lawfully marketed in another Member State will replace Regulation (EC) No 764/2008, and will introduce the following measures:
• a voluntary “mutual recognition declaration”, which businesses can use to demonstrate that their products are lawfully marketed in another EU country;
• a new problem-solving procedure, based on SOLVIT, to help businesses when mutual recognition is denied;
• stronger administrative cooperation to improve the application of the mutual recognition principle; and
• more information to businesses through “product contact points” and the “single digital gateway”.
30 The Mutual Recognition Principal stems from Regulation (EC) No 764/2008, which
defines the rights and obligations for public authorities and enterprises that wish to market their products in another EU country. The Regulation also defines how a country can deny mutual recognition of a product.
The “Mutual Recognition Principle” allows products not subject to EU-wide regulation to move freely within the Single Market.
New regulation on mutual recognition
19 Commons Library Briefing, 12 September 2019
3.2 Harmonised goods Harmonised sectors are subject to common rules across the EU. If manufacturers follow these rules, their products can be sold freely in the Single Market:
• In the majority of sectors (e.g. electronic and electric equipment, machinery, lifts, medical devices), EU legislation is limited to essential health, safety, and environmental protection requirements. ESOs are mandated by the European Commission to produce standards which define these requirements. To demonstrate compliance, manufacturers may voluntarily use standards or rely on other technical specifications.
• In other sectors (e.g. automotive and chemicals), legislation provides detailed requirements obliging certain types of products to have the same technical specifications.
Conformity assessment, a common feature of the New Approach Directives concerned with product safety, includes various checks on the:
• design and construction of products to meet essential requirements which normally are for health and safety;
• and being able to demonstrate this through a technical file
before declaring and certifying a products' conformity with all relevant Directives, and affixing CE marking to the product.
Some products can be self-certified through this process, but others must be tested by an EU-accredited notified body before the manufacture can declare conformity. At present, manufacturers can apply to any notified body31 in the EU and once they have the necessary certification their products can be sold anywhere in the Single Market.
3.3 CE Marking CE marking represents a declaration by the manufacturer that the product complies with all relevant EU legislation that mandates compliance with specific standards and requirements concerning product safety, environmental impact, consumer protection etc. It is the responsibility of the manufacturer to ensure that the product is appropriately marked.
The CE mark indicates compliance not with a specific standard but with the “essential requirements” stated in the harmonising measure (a directive or regulation). However, compliance with the standard designated for that measure confers a presumption of compliance with the essential requirements, and this is the route usually taken by manufacturers.
31 A notified body is an organisation that has been designated by an EU Member State
(the designating authority) to assess whether manufacturers and their products meet the requirements set out in legislation. For example, in respect of medical devices, the Medicines and Healthcare Products Regulatory Agency (MHRA) is the designating and competent authority in the UK.
A CE mark serves as a sign of assurance for consumers and other end users of products.
20 Brexit: product standards and safety marking
Sometimes (e.g. in a novel product) there is no relevant standard, and the manufacturer can simply claim (self-certify) and, if necessary, prove that the product meets essential safety requirements.
Within the EU and the broader EEA, the marketing and sale of products which carry a CE mark cannot be restricted unless there is evidence of non-compliance with the underlying EU legislation justifying such restriction.
A CE mark does not mean that a product complies with all other EU legislation that applies to that product. CE marking is in addition to other legal requirements in respect of consumer protection, product safety, environmental protection etc.
3.4 The General Product Safety Directive The General Product Safety Directive (GPSD) 2001/95/EC requires that all consumer products on the EU market are safe. The Directive is intended to ensure a high level of product safety throughout the EU for consumer products that are not covered by sector-specific EU harmonisation legislation. It also contains market surveillance provisions aimed at guaranteeing a high level of consumer protection.
The EU recognises that national legislation may set legal requirements as to the safety of consumer goods that go well beyond the Directive’s general safety requirement. For example, the UK’s Furniture and Furnishings (Fire Safety) Regulations 1988 (as amended) set levels of fire resistance for domestic upholstered furniture, furnishings etc and makes mandatory the observance of a British standard.
Importantly, the GPSD set up the Rapid Alert System, which ensures that the relevant authorities (including the European Commission) are quickly informed of dangerous non-food products on the Single Market. The system has now been extended by Regulation (EC) No 765/2008 to apply to all harmonised industrial products irrespective of the final user (i.e. professional products) and to products posing risks to other protected interests than health and safety (for example, risks to the environment). Subject to certain conditions, Rapid Alert System notifications can also be exchanged with non-EU countries.
In the UK, the GPSD is implemented by the General Product Safety Regulations 2005, which apply to any business involved in the import, manufacture and supply of goods to consumers. Under the Regulations, all products intended for, or likely to be used by, consumers under normal or reasonably foreseeable conditions must be safe. Products must be safe when they are available for supply or “placed on the market”. This occurs when a manufacturer first makes the product available for supply or when an importer takes ownership of the goods once they have been cleared by customs.
For the purposes of the Regulations, products are “supplied” when they are:
• sold, even if no money has been exchanged (e.g. products as a prize or gift is supply);
Consumer products not covered by sector-specific EU harmonisation legislation.
21 Commons Library Briefing, 12 September 2019
• hired (including hire purchase and letting);
• lent to consumers; and
• part of a contract for work
It is important to note that when considering whether a product is safe, consideration will be given to every characteristics of the product, including its packaging. If a product is unsafe, the business could face criminal prosecution; be forced to recall its products from consumers; and withdraw the product from the market. In addition, consumers might begin a legal action against the business to recover damages for any harm caused.
A separate Library briefing paper, “Product safety and recall” (CBP 8211) provides an overview of the current product safety regime in the UK. It considers product safety regulation; the remit of the new Office for Product Safety and Standards (OPSS); and recall policies. It also looks at the recent government commissioned review on the effectiveness of the UK’s product safety regime and why success rates for product recall are low. A report on the findings of this review was published in February 2016.32
32 “UK Consumer Product Recall – An Independent Review by Lynn Faulds Wood”,
February 2016, [online] (accessed 12 September 2019)
22 Brexit: product standards and safety marking
4. No-deal Brexit: impact on product safety regime
The May Government called for a comprehensive system of mutual recognition and a commitment to maintain UK regulatory standards in line with the EU’s.
Preparations are taking place across government to ensure that in the case that the UK leaves the EU without a deal, regulatory continuity will be ensured. This includes both the designation of standards to support regulations under the New Legislative Framework (NLF) and the introduction of a new UK regulatory mark that will be affixed to products or their packaging. According to the BSI,
“[…] the role of the UK Mark will be to support the authorities and provide clarity to manufacturers placing products on the market in the UK post-Brexit – but only in the case that the UK leaves the EU without a deal”.33
Further detailed information is set out below.
4.1 European Commission Notice On 22 January 2018, the European Commission (EC) issued a Notice setting out the effect Britain’s withdrawal from the EU may have on product safety standards in the event of a no deal, Notice to stakeholders – Withdrawal of the UK and EU rules in the field of industrial products. In this Notice, the EC stated that for industrial products to demonstrate compliance with CE Marking requirements for products placed on the EU market as from Brexit date:
“[…] economic operators are advised to take the necessary steps to ensure that, where the applicable conformity assessment procedures require the intervention of a Notified Body, they will hold certificates issued by an EU-27 Notified Body”.
In the absence of any other arrangement, the EC outlined its position as follows:
“[…] where economic operators hold certificates issued by a UK Notified Body prior to the withdrawal date and plan to continue placing the product concerned on the EU-27 market as from the withdrawal date, they are advised to consider either to apply for a new certificate issued by an EU-27 Notified Body or organising a transfer […] of the file from the UK Notified Body to an EU Notified Body”.
Simply put, EU legislation requires a notified body to be based in the EU. As from 31 October 2019, UK manufacturers wishing to sell to the EU would have to instruct EU based notified bodies. To demonstrate the potential impact of this Notice, a good example is medical devices. According to EU Commission data, almost half of all medical device products certified in the EU currently use UK notified bodies.
33 BSI, “Preparation for a possible “No Deal” Brexit – business as usual for standards”, 5
February 2019, [online] (accessed 12 September 2019).
23 Commons Library Briefing, 12 September 2019
The validity of hundreds of thousands of established UK conformity assessments may be called into question. In addition, some economic operators (i.e. manufacturers, importers and authorised representatives) currently operating from the UK, might see their designation change under CE marking legislation as well as their relevant obligations. For example, after Brexit, EU distributors established in the UK may become importers under CE marking legislation in relation to the products that they place on the EU market.
However, three points should be noted:
• First, some UK notified bodies may already have contingency plans in place to ensure that after Brexit global clients can continue to use them as their European notified body.
• Second, EU notified bodies, although they must be established in an EU country, can operate in third countries. It may be possible, therefore, for a UK-based body to establish a relationship with one based in the EU 27 and thus carry out its assessments in respect of both the EU and UK systems, given that the standards will be identical.
• Finally, the EU has bilateral arrangements whereby it recognises that conformity assessment bodies established in partner countries can give authoritative assessments on products vis-à-vis EU regulations. However, even where such arrangements exist they are often not comprehensive.
4.2 BSI continued membership of CEN & CENELEC
In November 2018, the BSI announced that it had reached an agreement with its counterparts in the European standards organisations - CEN and CENELEC – that secures its full membership and participation in the European standards system post-Brexit. The BSI set-out its position as follows:
A transition period for the CEN and CENELEC statutes will begin on the date of the UK’s effective withdrawal from the EU, until the end of 2020. The delayed date of Brexit does not affect the end date of this transition period.
This transition period introduces a derogation for BSI from certain eligibility clauses of the statutes. CEN and CENELEC have created a working group to determine a permanent solution for the statutes, to apply as of the end of 2020. At the same time BSI will undergo a review of its fulfilment of the membership criteria of CEN and CENELEC. BSI sees the decisions taken by the General Assemblies of CEN and CENELEC as a pragmatic solution that provides stability for the European standards system while meeting the needs of our stakeholders. BSI experts will be entitled, as now, to participate in CEN and CENELEC technical committees while BSI will continue to enjoy full voting rights in the decision-making bodies of both organizations. Crucially, furthermore, standards users in the UK can continue to be
24 Brexit: product standards and safety marking
confident that these standards will meet their needs as they will be influenced, as they are now, by UK stakeholders.34
According to this statement, the UK, through the BSI, will continue to commit to the fundamental membership principles of CEN and CENELEC, meaning that all member countries of CEN and CENELEC have a consistent and coherent catalogue of national standards for industry, consumers and regulators.
However, the implications of a “no deal” Brexit may still be significant. For instance:
• With minor exceptions, the CEN/CENELEC rules oblige each national member to implement all their standards and to have no rival standards. Assuming the UK continues the “reference to standards” approach to regulation, and that the BSI remains the sole standards making body in the UK (another CEN/CENELEC requirement), the only standards that UK regulations may refer to are those of CEN/CENELEC (except in a few areas where no EU measures exit).
• Standards that are referenced in NLF measures are drafted by CEN/CENELEC at the request (or mandate) of the European Commission. Furthermore, the Commission has a final say as to whether they are accepted (which is not a mere formality). The BSI maintains an optimistic view of its continued role in the CEN/CENELEC but there is a question mark over the extent of its participation in drafting mandated standards in the event of a “no-deal” Brexit.
• It is also fair to say that manufacturers largely rely on the texts of the standards referenced in NLF measures, rather than the measures themselves. These will be CEN/CENELEC standards mandated by the Commission. Of course, it is conceivable that a UK regulation could simply omit a standard from the list referenced in the EU measure, or completely abandon the “reference to standards” approach.
There is also the argument that a “no deal Brexit” presents an opportunity for the UK to reduce its regulatory burden. EUROCHAMBRES (the European Association of Chambers of Commerce and Industry) estimates the net cost to businesses of EU regulations introduced in the last 11 years is just over €1,036bn. 35 It is suggested that Brexit could lead to smarter regulation better targeted at the interests of the UK economy.36
34 “BSI: Brexit and Standards: BSI continues as member of CEN and CENELEC”, BSI EU
Exit update 11 April 2019, [online] (accessed 12 September 2019) 35 “Counting the cost of EU legislation to business”, EuroChambres, 6 September 2019,
[online] (accessed 12 September 2019) 36 Ibid
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4.3 The Product Safety and Metrology (Amendment etc.) (EU Exit) Regulations
This Statutory Instrument (SI) would amend UK product compliance legislation in the event of a no-deal Brexit.
In brief, the Product Safety and Metrology (Amendment etc.) (EU Exit) Regulations 2019 would correct deficiencies in UK legislation that gives effect to EU laws applicable to product safety so that the legislation would continue to operate effectively when the UK leaves the EU. The Regulations, made under section 8 of the European Union (Withdrawal) Act 2018, were made on 27 March 2019 and will come into force on Brexit day (in the event of no-deal).
The Regulations are extensive, running to 37 detailed schedules. The Explanatory Memorandum that accompanies the Regulations, states that the substantive law relating to product safety will continue to apply as before Brexit day. Most changes are therefore consequential in nature. To give a flavour, I would highlight the following points. The Regulations would:
• Amend primary and secondary legislation in the field of product safety by removing or amending references to EU legislation from UK legislation and revoking measures that would no longer be needed after exit day.
The amended legislation includes the Consumer Protection Act 1987 and the General Product Safety Regulations 2005 (SI 2005/1803) as well as numerous sector-specific regulations, such as the Toys (Safety) Regulations 2011 (SI 2011/1881) and the Electrical Equipment (Safety) Regulations 2016 (SI 2016/1101).
• Amend some secondary legislation pertaining to health and safety at work (such as the Lifting Operations and Lifting Equipment Regulations 1998 (SI 1998/2307).
• Revoke some direct EU legislation, including:
Regulation (EU) 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European Standardisation; and
Regulation (EC) 764/2008 rules to products lawfully marketed in another member state of the European Parliament and of the Council of 9 July 2008 laying down procedures relating to the application of certain national technical rules to products lawfully marketed in another member state; and repealing Directive 3052/95/EC.
• Amend references and definitions in affected legislation to ensure that they are appropriate after exit day. For example, substituting the “UK” for “CE” and empowering the Secretary of State (rather than European bodies) to act as the relevant authority, for approval or accreditation purposes (see below).
• Address metrology and make minor changes to the Weights and Measures Act 1985, subordinate legislation concerning weights and measures, and also to the Hallmarking Act 1973.
26 Brexit: product standards and safety marking
In the event of a no-deal Brexit, changes to compliance processes will need to be implemented to ensure that UK products have UK markings and the relevant UK guidance and processes are followed where there is a question over product safety. Specifically, the following points should also be noted:
• The market - definitions of “placing on the market” and “making available on the market” would be restricted to the UK market alone, as opposed to the whole EEA market. This is aimed at ensuring that UK product safety laws are focused on goods sold to consumers in the UK.
• UK Compliance - the European CE marking regime, which signifies compliance with product safety laws, would be replaced in the UK with a new “UK Conformity Assessed” marking regime (‘UKCA’). Information on the use of this marking can be found on the Gov.UK website.
If Britain exits the EU without a deal, in most cases CE marking would still be used for products being placed on the UK market for a time-limited period. However, where a product requires a third-party assessment of conformity, and if that assessment is carried out by a UK notified body, the new UKCA mark should be applied.
• Powers of the Secretary of State – in the event of a no-deal, the Secretary of State would take on the role of EU authorities for the regulation of product safety. This means that the Secretary of State would issue UK standards, guidelines and provide a UK database of product safety and market surveillance information to replace the current EU structures, such as reporting to Rapex.
4.4 New UKCA mark
Box 6: The UK Conformity Assessed (UKCA) marking
This is the design for the UK marking for certain products to be sold in the UK, which would replace the CE marking in the event the UK leaves the EU without a deal.
As already mentioned, preparations are taking place across government to ensure regulatory continuity in the event of the UK leaving the EU without a deal. This includes the introduction of a new UK regulatory mark that will be affixed to certain products or their packaging. The
Changes to compliance processes
A new “UK Conformity Assessed” marking
A new UKCA mark
27 Commons Library Briefing, 12 September 2019
purpose of this new UKCA mark will be to support the authorities and provide clarity to manufacturers placing products on the UK market post-Brexit. It is important to note that if a UKCA mark is required, it will be underpinned by the same British standards as current legislation. In addition, the concept of “harmonised standards” will be transferred into the UK legal order to become identical “designated standards”. From exit day the Secretary of State will cite designated standards for the purposes of providing a presumption of conformity with the applicable regulation, in the same way as the European Commission cites European standards.
New designated standards
28 Brexit: product standards and safety marking
5. No deal Brexit: what it means for manufacturers
5.1 Overview This section (and Box 7 below) considers the possible implications of a no-deal Brexit on UK manufacturers who place products on both the UK and EU markets. It should be noted that the following technical guidance has been issued by the UK government:
• Placing of manufactured products on the UK market if there is a no-Brexit deal, 19 March 2019.
• Placing manufactured goods on the EU internal market if there’s no Brexit deal, 9 March 2019.
• On 26 February 2019, the Government issued similar advice in respect of construction products and medical devices.
Box 7: Obligations on manufacturers
Current position • Currently, the CE mark is required to be affixed on many products (including medical devices,
toys, machinery and electrical equipment) placed on the market in the EU to indicate compliance with the relevant EU legislation on product safety.
• In many cases, products can be self-declared as compliant by the manufacturer, who can then affix the CE marking. For some products, however, the product needs to be assessed by a third-party conformity assessment body (a so-called “notified body”) to ensure that the EU safety requirements are met.
In the event of a no-deal Brexit • The government has published guidance on the new “UKCA” product mark, which mirrors the
CE mark for certain products placed on the UK market in the event of a no-deal Brexit.
• To minimise disruption, CE marked products will continue to be permitted on the UK market, albeit for an unspecified time-limited period.
• In accordance with the EU’s Notice to stakeholders – Withdrawal of the UK and EU rules in the field of industrial products, UK conformity assessment bodies (or UK-based authorised representatives) will no longer be recognised by the EU, meaning that conformity assessments carried out by them can no longer support the affixing of a CE mark. A CE mark is a pre-requisite for placing products on the European market.
29 Commons Library Briefing, 12 September 2019
5.2 Placing products on the UK market after a no-deal Brexit
Box 8: Placing products on the UK market in the event of a no-deal Brexit
“UKCA” (UK Conformity Assessed) marking is the new UK product marking that will be used for certain goods placed on the UK market, if the UK leaves the EU without a deal. The UKCA marking is concerned with the UK market only. As such, the marking will not be recognised on the EU market and products for sale in the EU that currently need a CE marking will continue to need a CE marking.
Following a no-deal Brexit and for a time-limited period, the manufacturer has a choice when placing goods on the UK market:
• continue to rely (for the time being at least) on the CE mark to place the products on the market in the UK, or
• apply the new UKCA mark. During the time-limited period, to place CE marked goods on the UK market after the UK leaves the EU, the manufacturer will need to ensure that these goods:
• meet the essential requirements as set out in the EU legislation;
• have undergone the relevant conformity assessment procedure (including by an EU recognised body, where required); and
• display the relevant EU conformity marking (such as the CE marking). In addition, the manufacturer must ensure that technical documentation and an EU declaration or attestation of conformity are available on request. It is important to note that the manufacturer will still be able to use CE marking based on self-declaration of conformity, when placing products on the UK market. Once this time-limited period ends, only UKCA marking will be recognised in respect of the UK market. A product bearing a CE mark would still be valid for sale in the UK provided it is also UKCA marked and complies with the relevant UK rules.
As outlined in Box 8 above, the government has made provision for a new UKCA mark. Most, but not all, products to which a CE mark must currently be applied will fall within scope of the new UK product marking regime following a no deal Brexit. The rules around using the new UKCA mark will mirror those which currently apply for the application of the CE mark.
After the UK leaves the EU, manufacturers will still be able to place on the UK market goods which have been made and assessed against EU regulatory requirements and then CE marked. However, this is intended to be for a time-limited period only. The UK Government has said it will consult with industry and provide notice before ending this time-limited period.
Continued use of CE mark for a time - limited period
30 Brexit: product standards and safety marking
During this time-limited period, it will be possible in most cases to use only the CE mark for products being placed on the UK market. However, there is one exception. This is where the products in question require third party assessment of conformity, and that has been carried out by a UK conformity assessment body. In such circumstances, it will be necessary to apply the new UKCA mark as from exit day. This will not be the case however if the certificate of conformity has been transferred to an EU-recognised body before then (in which case the CE mark could still be applied, making the products acceptable for the UK market).
For products which currently only require self-declaration of conformity for the CE mark to be applied, it is possible to apply the new UKCA mark based on that self-declaration. In these cases, it would be possible to use either marking, or to use both CE and UKCA marking on the same product.
During this time-limited period, the new UKCA mark is intended to be complimentary to the CE mark and not replace it. It is envisaged that the UKCA mark could be used where the manufacturer is unable to apply a CE mark (for example, where the manufacturer has used a UK Approved Body rather than an EU notified body, and only wishes to place their products on the UK market).
After the time-limited period, only the UKCA mark will be recognised in respect of the UK market. A product bearing the CE mark would still be valid for sale in the UK provided it is also UKCA marked and complies with the relevant UK rules.
5.3 Placing products on the EU market after a no-deal Brexit
Box 9: Placing products on the EU market in the event of a no-deal Brexit
• Products currently requiring CE marking will continue to require a CE mark if they are to be offered for sale in the EU. The UKCA mark will not be recognised on the EU market,
• Some goods made and sold in the UK and exported to the EU may have to be stamped with two marks: a CE mark for EU markets and a UKCA mark for the UK. For some products that could also mean two sets of tests.
Other possible implications include:
• Manufacturers who use a UK Approved Body might need to contact that body to understand their post Brexit position and whether the new UKCA mark is more appropriate for their product.
• For manufacturers who distribute through an EU supply chain, changes to the “economic operator” status of that supply chain may require changes to packaging.
• Manufacturers of machinery who intend to place products on the EU market following a no-deal Brexit, may need to nominate a person based in the EU who is responsible for compiling the Technical File.
31 Commons Library Briefing, 12 September 2019
CE marking is integral to the Single Market so, in the absence of any other arrangement (in the event of a no deal Brexit), the UK will need to apply the rules if it wants to continue to trade with the EU, even if it adopts a new UKCA marking system in respect of internal trade. The new UKCA mark will not be recognised in the EU.
Assuming the EU abides by its Notice to stakeholders – Withdrawal of the UK and EU rules in the field of industrial products, UK conformity assessment bodies (or UK-based authorised representatives) will no longer be recognised by the EU, meaning that conformity assessments carried out by them can no longer support the affixing of a CE mark (a pre-requisite for placing products on the European market). This may necessitate the re-assessment of products by an EU recognised notified body before they can be placed on the EU market.
BRIEFING PAPER Number 8583 12 September 2019
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