Market Surveillance and Notified Bodies
A number of state agencies undertake a wide range of product safety, market surveillance and accreditation roles, which are vital to the efficient functioning of the economy and essential to the maintenance of the Single Market. Even the most benign of Brexit conditions would result in a step change in the regulatory landscape.
The Government provided additional resources in Budget 2019 to support the work of four Regulatory Agencies in the context of Brexit: the Health and Safety Authority (HAS); the Competition and Consumer Protection Commission (CCPC); the National Standards Authority of Ireland (NSAI); and the Irish Auditing and Accounting Supervisory Authority (IAASA), as well as providing additional resources to the Irish National Accreditation Board (NSAI).
Market surveillance activities, carried out, for example, by the CCPC, NSAI and the HSA, ensure that products placed on the EU market are designed, manufactured and monitored in accordance with EU legal requirements. In the event of a no deal Brexit, Ireland will no longer be able to rely on UK market surveillance authorities to check compliance of products coming into the UK from non-EU countries and coming directly from the UK. The relevant market surveillance authorities, therefore, will have a statutory responsibility to undertake significantly increased market surveillance checks in Ireland across a range of consumer, industrial and chemical products.
In a no deal Brexit scenario, companies in Ireland will no longer be able to rely on UKbased Notified Bodies to test, certify and inspect their products/services. Manufacturers currently relying on a UK Notified Body for conformity assessment of products must arrange either for a transfer of their files and the corresponding certificates from the UK body to an EU27 Notified Body or apply for a new certificate with an EU27 Notified Body. Importers, distributors and authorised representatives should ensure that they hold certificates under the responsibility of an EU27 Notified Body. Likewise, exporters currently relying on UK based Notified Bodies for compliance certification will need to make similar alternative arrangements. In addition, authorised representatives and importers under the Construction Products Regulation (CPR) are both required to be established in the EU27.
A number of UK-based Notified Bodies are in the process of establishing themselves in Ireland and gaining INAB accreditation to enable them to remain as EU Notified Bodies. This process is highly regulated by EU legislation and there is no guarantee that all the applicant UK notified bodies will be accredited before the Brexit deadline. INAB has awarded eight new Brexit-related accreditations since January 2019. As of the end of May 2019 there were 17 applications for accreditation at various stages of assessment by INAB for a range of products, including machinery, personal protective equipment, construction products, transportable pressure equipment, radio equipment, electromagnetic capability and marine equipment.
Although accreditation is awarded by INAB, INAB is not a Notifying Authority; the process of appointing Notified Bodies is separate and is carried out by designated Notifying Authorities. A number of government departments and state bodies are Notifying Authorities in respect of the various EU Directives. This includes Comreg, the HPRA and the Department of Housing, Planning and Local Government (DHPLG) as well as the Department of Business, Enterprise and Innovation (DBEI), the Department of Transport, Tourism and Sport (DTTAS) and the Department of Justice and Equality.
While the number of Notified Bodies legally designated in Ireland will increase, in a no deal Brexit there will not be the same range of Notified Bodies available to manufacturers in Ireland, who will be obliged to use Notified Bodies in another EU Member State. It is important to note that Notified Bodies are available throughout the EU27, and certification can be provided through bodies based in any EU Member State that are appropriately accredited.
Given the reliance by Irish manufacturers on the services of UK-based Notified Bodies, Government renews its call on businesses that use UK Notified Bodies to source an EU-based Notified Body legally designated to carry conformity assessments instead. A list of Notified Bodies is available on the EU ‘NANDO’ website.
Sector Specific Product Certification
There are approximately 50 UK Notified Bodies certifying a wide range of construction products for the EU Market. The Irish construction industry is quite import dependent in terms of inputs – about one third of inputs (goods and services) are imported, and of those about 40% of goods come from the UK. A range of construction products and materials is subject to CPR regulation in circulation in the Single Market. These must be compliant with EU standards, many of which require assessment and authorisation by Notified Bodies established in an EU Member State. Authorised representatives and importers under the CPR are both required to be established in the EU27.
DHPLG is the notifying authority for the Construction Products Regulation (CPR) in Ireland, carrying out the assessment of bodies applying for Notified Body status in Ireland for construction products, and the notification of recommended Notified Bodies to the Commission. Bodies seeking Notified Body status for the purpose of the CPR must first apply to INAB for accreditation. Up to February 2019, DHPLG had granted Notified Body status to one organisation: the National Standards Authority of Ireland (NSAI). Since then a further three organisations have been granted notified body status of which two are connected to notified bodies based in the UK. INAB continues to work with a further six candidate bodies.
It is not clear whether or not all construction products currently certified in the UK are also certified in other EU Member States. While it is expected that this would be the case for the majority of products, there is a risk that a small number of products may no longer be available in the EU in the event of a no deal Brexit (this is an issue for all EU MS, not just Ireland).
A similar reliance on UK Notified Bodies exists for the certification of medical devices and engagement with industry and the Commission in underway as set out in the chapter on supply of medicines and medical devices.
In December 2018 the Office of Government Procurement published an information note on Brexit and public procurement which it revised in June. It highlighted the various steps a public body should consider to prepare for Brexit including examining their supplier bases to assess their exposure to the UK market.
Over the period to end-October:
The Government will continue to support increased capacity amongst relevant regulatory bodies.
Businesses that use UK Notified Bodies should source an EU-based Notified Body legally designated to carry conformity assessments instead. A list of Notified Bodies is available on the EU ‘NANDO’ website.
Companies that source products from the UK should engage with the NSAI for support and guidance on standards and certification.
Importers and suppliers should carry out a risk assessment of their product supply chain to highlight any materials that may be impacted and identify potential alternative certified sources within another Member State.
Organisations who use products sourced from the UK should engage with their suppliers to satisfy themselves that product supply continuity is resilient and will be maintained.