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Delivering the deal negotiated with the EU remains the government’s top priority. This has not changed.
However, the government must prepare for every eventuality, including a no deal scenario. For 2 years, the government has been implementing a significant programme of work to ensure that the UK is prepared to leave the EU on 29 March 2019.
It has always been the case that as we get nearer to that date, preparations for a no deal scenario would have to be accelerated. We must ensure plans are in place should they need to be relied upon.
In the summer, the government published a series of 106 technical notices setting out information to allow businesses and citizens to understand what they would need to do in a no deal scenario so they can make informed plans and preparations.
This technical notice offers guidance for continued planning in the event of no deal.
Also included is an overarching framing notice explaining the government’s approach to preparing the UK for this outcome in order to minimise disruption and ensure a smooth and orderly exit.
We are working with the devolved administrations on technical notices and we will continue to do so as plans develop.
If the UK leaves the EU without a deal on 29 March 2019, the requirements for placing certain products on the UK and EU markets, including the arrangements for conformity assessment, marking and labelling, will change.
This notice explains the future arrangements for the regulation of most goods covered by the EU’s New Approach in a ‘no deal’ scenario. It includes those regulated under the ‘New Legislative Framework’ as well as machinery. In particular it covers arrangements for conformity assessment (the assessment of goods to ensure they meet relevant requirements). These goods are subject to EU-wide product specific rules.
This notice does not cover the following areas:
- Automotive (Vehicle type approval)
- Aerospace (Aviation safety)
- Pharmaceutical products (Batch testing medicines, Medicines, Medical Devices and Clinical Trials, further guidance on the regulation of medicines, medical devices and clinical trials, Submitting regulatory information on medical products)
- Medical devices (Medicines, Medical Devices and Clinical Trials, Submitting regulatory information on medical products)
- Chemicals (Regulating chemicals, classifying, labelling and packaging chemicals)
- Goods subject to national regulations (Non-harmonised goods)
- Construction products
Annex A sets out the specific EU goods regulations and directives covered by this notice. This list may be updated over time.
Annex B provides additional detail regarding civil explosives.
Annex C provides additional information for current UK Notified Bodies.
Before 29 March 2019
For the products covered by this notice EU legislation sets out the rules, or ‘essential (safety) requirements’, which products must meet before they are placed on the EU market.
For some of these product areas, manufacturers can choose to demonstrate compliance with the essential requirements set out in legislation by following ‘harmonised standards’. Harmonised standards that can be used to demonstrate that a product meets essential requirements are cited in the Official Journal of the European Union.
The relevant EU legislation sets out how products within its scope can be assessed to prove that they conform with the essential requirements. Typical ways of showing conformity include:
- self-declaration by the manufacturer that they have taken appropriate steps to ensure their product is compliant (for example, for most toys)
- assessment of the final product by an EU-recognised body (known as a ‘notified body’. A notified body is an organisation designated by an EU country (or a third country covered by a mutual recognition agreement with the EU) to assess the conformity of certain products before they are placed on the market.)
- assessment of a product’s design (or a prototype) by a notified body, followed by assessment of either a sample of the final product or quality assurance of production processes
For many products, a manufacturer must affix a ‘conformity marking’, most commonly the CE marking. This acts as a declaration by the manufacturer that the product complies with the relevant requirements. For marine equipment, the wheel mark as defined in the Marine Equipment Directive, 2014/90/EU) is used.
Where EU rules require third party assessment, that notified body’s 4-digit identification number (as listed on the EU’s New Approach Notified and Designated Organisations database, known as NANDO) must also be affixed to the product.
Notified bodies are usually given the right to carry out conformity assessment following assessment by a national accreditation body (in the UK, the United Kingdom Accreditation Service). They are then formally ‘notified’ to the European Commission and other EU countries by the relevant public body and listed on the NANDO database.
After March 2019 if there’s no deal
Goods already placed on the market by 29 March 2019 will be able to continue to circulate in the UK. Additionally, goods made and assessed against EU regulatory requirements can continue to be placed on the UK market after 29 March 2019. This is intended to be for a time-limited period. These goods will need to:
- bear the appropriate EU conformity marking (such as the CE marking)
- be accompanied by an EU declaration or attestation of conformity (in English)
- have been assessed by an EU-recognised body, where third party assessment is required
UK notified bodies will lose their status as notified bodies in the EU. This means that after 29 March 2019 the results of conformity assessment carried out by UK conformity assessment bodies will no longer be recognised in the EU. This means that products assessed by a body that was prior to exit a UK notified body will no longer be able to be placed on the EU market without reassessment and re-marking by an EU recognised conformity assessment body (or, alternatively, the manufacturer may seek to arrange for their files to be transferred to an EU-recognised body pre-exit). Where CE marking is based on self-declaration of conformity by the manufacturer, self-declaration will still be possible, including when exporting to the EU.
For the areas within scope of this notice (see Annex A), notified bodies based in the UK will be granted new UK ‘approved body’ status and listed on a new UK database (see Annex C). Approved bodies will be able to assess products for the UK market against UK essential requirements (which, immediately after exit day, will be the same as EU essential requirements).
Manufacturers selling goods on the UK market will then be able to affix a new UK conformity marking before placing a product on the UK market. Rules around affixing the new UK conformity marking will mirror those which currently apply for the application of the CE marking.
A separate UK marking to replace the wheel mark will be in place for marine equipment. Manufacturers will not need to use these markings from the point of exit if they have used the relevant EU marking after having their product assessed by an EU recognised body (where third party assessment is required). This is intended to be for a time-limited arrangement. Details of these markings will be published in early 2019 and with sufficient time to allow businesses to prepare.
The results of conformity assessment carried out by UK notified bodies prior to 29 March 2019 will continue to be recognised after 29 March 2019 on the UK market. However, other than where items are ready for placing on the market[footnote 1], manufacturers continuing to rely on such conformity assessment by UK bodies will need to use the UK marking. This does not apply where certificates of conformity have been transferred to an EU-recognised body.
Where the CE marking is currently used on the basis of self-declaration, then during the intended time-limited period of ongoing recognition of the CE marking manufacturers will have the choice to use either the UK or CE marking (or both). However, products being sold on the EU market will require the CE marking as well as needing to meet all other EU requirements.
The United Kingdom Accreditation Service’s (UKAS) role as the UK’s national accreditation body, including for most UK conformity assessment bodies, will remain as it is now. Other UKAS accreditation activities will be unaffected by EU Exit.
Existing harmonised standards (used to demonstrate conformity with EU essential requirements) will become UK ‘designated standards’. UK businesses will be able to continue to use standards as a way of demonstrating conformity with UK essential requirements: following the standards will still give rise to a presumption of conformity with the essential requirements, where following harmonised standards does now. The UK will publish a full list of the references of UK designated standards. As noted above, immediately following exit these will be identical to EU harmonised standards published in the Official Journal for the purposes of the EU legislation.
BSI will remain the UK’s National Standards Body and the UK member of CEN and CENELEC. This will provide the means for UK industry experts and other stakeholders to represent UK views into CEN and CENELEC’s standards development activities. BSI’s membership of the international standards bodies, ISO and IEC is unaffected.
The UK’s robust market surveillance system will continue to work to limit the number of unsafe and non-compliant goods on the UK market. The UK is retaining protections in domestic law including those which provide powers for market surveillance enforcement to ensure that unsafe and non-compliant products can swiftly be removed from the UK market.
The government is developing UK replacements to the EU databases, including a new product safety market surveillance database to ensure we are able to quickly identify new threats to mount coordinated and rapid responses to those threats and to target the interception of high-risk products, including imports.
All manufacturers intending to place products on the UK market on or after 29 March 2019 will want to consider the actions outlined below.
All manufacturers placing products on the EU market will need to take the actions outlined below if they intend to place products on the EU market on or after 29 March 2019
Actions for businesses and other stakeholders
Manufacturers placing products on the UK market should note:
- Products that meet EU requirements can continue to be placed on the UK market without any need for reassessment or re-marking, including where any assessment required is carried out by an EU-recognised body. It is intended that this will apply for a time-limited period and sufficient notice will be given to businesses before that period ends.
- Products that meet UK requirements and bear a UK conformity marking can be placed on the UK market, as long as any third-party assessment required has been carried out by a UK-recognised conformity assessment body.
- Products that have undergone the complete process of manufacturing and conformity assessment (i.e. which are ready for placing on the market) can still be placed on the UK market with a CE Marking after 29 March 2019. However, where manufacturers have not completed the process of manufacturing and intend to continue to rely on conformity assessment carried out by a UK-based conformity assessment body without transferring their files to an EU-recognised equivalent, the UK marking will be required instead of the CE marking after 29 March 2019.
- For product areas covered by this notice, UK-based notified bodies will become UK approved bodies after March 2019 and will be listed on a new UK database (see Annex C).
Manufacturers placing products on the EU internal market should note:
- Products which were assessed by a UK-based notified body will need to be reassessed by an EU-recognised conformity assessment body before placing on the EU market (A list of EU-recognised conformity assessment bodies can be found on the NANDO database. After March 2019, UK-based bodies will no longer be listed on this database)
- Alternatively, manufacturers can seek to arrange for their files to be transferred to an EU-recognised notified body pre-exit to allow for certificates of conformity issued by a UK-based notified body to continue to be valid
- In either of the scenarios above, products where third-party assessment is required would need to be re-marked with the new EU-recognised notified body’s 4-digit number
- Where manufacturers use the CE marking based on self-declaration this can still be used when exporting goods to the EU
An EU-based economic operator or UK based economic operator who used to act as a ‘distributor’ may be legally, now, be considered an ‘importer’ and may acquire additional legal responsibilities for checking product compliance. In some cases, this may mean that an importer address must be included on the product or its packaging. Whether this is the case can vary depending on product or exact scenario.
Distributors who bring products in from the EU to the UK will in most cases now be classified as ‘importers’ bringing in products to the UK from a third country. This change in status will bring new obligations such as the requirements for importers to label their products with their name and address. Other obligations of importers are that they must ensure that the relevant conformity assessment procedure has been carried out; that the manufacturer has drawn up the technical documentation; that the product bears the conformity marking and inscriptions and that the manufacturer has complied with their labelling obligations. Furthermore, importers must not place products on the market where they have reason to believe that the product is not in conformity with the essential requirements.
However, the government is introducing an 18-month transitional period, after 29 March 2019, during which importers of products from the EU may put information identifying them on an accompanying document (rather than the product itself). This transitional measure only applies to businesses who import products to the UK from the EU (including the EEA).
A separate notice is planned for construction products.
Where the government makes changes to any of the above arrangements, for example, regarding the ongoing recognition of conformity assessment activities carried out by EU bodies – it will ensure businesses are provided with adequate notice.
This notice is meant for guidance only. You should consider whether you need separate professional advice before making specific preparations.
It is part of the government’s ongoing programme of planning for all possible outcomes. We expect to negotiate a successful deal with the EU.
The UK government is clear that in this scenario we must respect our unique relationship with Ireland, with whom we share a land border and who are co-signatories of the Belfast Agreement. The UK government has consistently placed upholding the Agreement and its successors at the heart of our approach. It enshrines the consent principle on which Northern Ireland’s constitutional status rests. We recognise the basis it has provided for the deep economic and social cooperation on the island of Ireland. This includes North-South cooperation between Northern Ireland and Ireland, which we’re committed to protecting in line with the letter and spirit of Strand two of the Agreement.
The Irish government have indicated they would need to discuss arrangements in the event of no deal with the European Commission and EU countries. The UK would stand ready in this scenario to engage constructively to meet our commitments and act in the best interests of the people of Northern Ireland, recognising the very significant challenges that the lack of a UK-EU legal agreement would pose in this unique and highly sensitive context.
It remains, though, the responsibility of the UK government, as the sovereign government in Northern Ireland, to continue preparations for the full range of potential outcomes, including no deal. As we do, and as decisions are made, we’ll take full account of the unique circumstances of Northern Ireland.
Norway, Iceland and Liechtenstein are party to the Agreement on the European Economic Area and participate in other EU arrangements. As such, in many areas, these countries adopt EU rules. Where this is the case, these technical notices may also apply to them, and EEA businesses and citizens should consider whether they need to take any steps to prepare for a ‘no deal’ scenario.
Annex A - EU directives and regulations covered by this notice
- Regulation for Accreditation and Market Surveillance – 765/2008
- Toy Safety - Directive 2009/48/EU
- Restriction of Hazardous Substances in Electrical and Electronic Equipment - Directive 2011/65/EU
- Pyrotechnic Articles - Directive 2013/29/EU
- Recreational craft and personal watercraft - Directive 2013/53/EU
- Civil Explosives - Directive 2014/28/EU
- Simple Pressure Vessels - Directive 2014/29/EU
- Electromagnetic Compatibility - Directive 2014/30/EU
- Non-automatic Weighing Instruments - Directive 2014/31/EU
- Measuring Instruments - Directive 2014/32/EU
- Lifts - Directive 2014/33/EU
- ATEX - Directive 2014/34/EU
- Radio equipment - Directive 2014/53/EU
- Low Voltage - Directive 2014/35/EU
- Pressure equipment - Directive 2014/68/EU
- Marine Equipment - Directive 2014/90/EU
- Personal protective equipment - Regulation (EU) 2016/425
- Gas appliances - Regulation (EU) 2016/426
- Machinery Directive – Directive 2006/42/EC
- Noise emission in the environment by equipment for use outdoors – Directive 2000/14/EC
- Ecodesign directive – (2009/125/EC)
Annex B - Additional information relating to civil explosives
Before 29 March 2019
Currently anyone importing civil explosives into the EU, or transferring them through the EU, requires an approval from the EU country where the transfer ends. This is called an Intra Community Transfer approval and each EU country through which the civil explosives transfers must also add their authorisation for the transfer to the Intra Community Transfer.
Civil explosives manufactured in, or imported to, the EU must be marked with a unique site code provided by an EU country to the manufacturer or EU-based importer. This code is recognised by all EU countries. An accompanying record must be held to enable traceability of the civil explosive through the supply chain.
Civil explosives manufactured in the EU for export, do not need a unique identification mark if the importing third country requires an identification which allows for traceability of the explosives.
After March 2019 if there’s no deal
As the UK will not be an EU country for the purposes of transfers of civil explosives through the EU internal market, the UK will not be able to issue an Intra Community Transfer.
This means that any transfers (now imports) of civil explosives to the UK will need a standalone approval from a UK competent authority (Great Britain or Northern Ireland depending on where the transfer ends in the UK) before the civil explosives are imported. Intra Community Transfer approvals issued by UK competent authorities prior to exit for multiple transfers will continue to be recognised until they expire.
The UK will recognise existing site codes on civil explosive products imported to the UK where the site code has been issued by another Member State. The UK will not require importers to add a new code. However, to continue effective traceability through the supply chain, all importers will need to contact a UK competent authority (Great Britain or Northern Ireland depending on the place of import) to notify them of any existing site code on the civil explosives being imported. The competent authority will then link this existing code to the UK based importer.
As now, where civil explosives are manufactured in the UK for export, a unique identification mark is not required if the importing third country, such as an EU Member State, requires an identification which allows traceability of the explosives.
The UK government will continue to work with the Northern Ireland Civil Service to ensure that a coherent civil explosives regime continues to operate across the UK.
Any UK business, who previously obtained an Intra Community Transfer (approval from a UK competent authority (Great Britain or Northern Ireland depending on where the transfer ended)) for a transfer across the EU internal market, will now need to obtain an Intra Community Transfer from the final Member State where the transfer ends in the EU internal market.
A new UK approval for the transfer (now import) to the UK will then be required from the relevant UK competent authority (Great Britain or Northern Ireland depending on where the transfer ends in the UK).
Any importer of civil explosives to the UK will need to contact the relevant UK competent authority (Great Britain or Northern Ireland depending on where the civil explosives are imported to) to provide them with details of any existing site code on the civil explosive product.
Civil explosives manufactured in the UK for export to the EU can be marked to meet the requirements of the EU as they require an identification which allows for traceability of the explosives.
Businesses dealing with civil explosives may also want to consider the separate technical notice on export controls.
Annex C – UK Approved Bodies
Existing UK notified bodies will be automatically become UK approved bodies under all relevant legislation listed at Annex A.
There will be no need for existing notified bodies to seek re-accreditation in order to benefit from UK approved body status.
In early 2019 notified bodies established in the UK will be contacted and asked to confirm whether they wish to acquire approved body status, and if so under which areas of product regulation.
Unless UK notified bodies decide to stop activities, under the new UK framework, they will be automatically granted this status as soon as the UK leaves the EU. They will be listed on a UK version of the NANDO database and given a 4-digit approved body number. The current intention is that this will be the same number as the existing notified body number, to allow for identification of the relevant approved bodies responsible for CE marked products already in use or circulation on the market.
Where UK notified bodies indicate that they do not intend to operate under the UK framework, their status will be withdrawn on exit day and they will not be listed in the new UK database of Approved Bodies. As part of this, bodies not intending to operate will need to either transfer relevant documentation to another approved body or the relevant government department or to retain relevant documentation for a specified period.
More details will be provided in early 2019. Notified bodies based in the UK do not need to take any action before this time.
Products that have undergone the complete process of manufacturing and conformity assessment (i.e. which are ready for placing on the market) can still be placed on the UK market with a CE Marking after 29 March 2019. ↩