101 UK Brexit Notes

Connemara Programme October 16 2018 pg. 87 Business: Regulation: EU’s New Approach Purpose This notice explains the future arrangements for the regulation of most goods covered by the EU’s New Approach, which includes those regulated under the ‘New Legislative Framework’ as well as machinery. In particular, it covers arrangements for conformity assessment (the testing of goods to ensure they meet relevant requirements). These goods are subject to EU-wide product specific rules. These arrangements will apply in the unlikely event that the UK exits the EU without a deal in March 2019. This notice does not cover the following areas:  Automotive ( Vehicle type approval )  Aerospace  Pharmaceutical products ( Batch testing medicines , 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  Goods subject to national regulations ( Non-harmonised goods ) 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. 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 published in th e Official Journal of the European Union . For construction products, use of the harmonised standards is mandatory. The relevant EU legislation sets out how products within its scope can be tested 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-accredited body (known as a ‘notified body. A notified body is an organisation designated by an EU country to assess the conformity of certain products before being placed on the market.)  assessment of a product’s design (or a prototype) by a notified body, followed by testing 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 (CE marking is defined in EU law as “a marking by which the manufacturer indicates that the product is in conformity with the applicable requirements set out in [EU] harmonisation legislation providing for its affixing”). This acts as a declaration that the product complies with the relevant requirements. For marine equipment, the wheel mark (The Wheel Mark (Mark of Conformity) is the European regulatory marking of all marine equipment, as defined in the Marine Equipment Directive, 2014/90/EU) is used. Where EU rules require third party testing, that notified body’s four-digit identification number (as listed on the EU’s New Approach Notified and Designated Organisations database, known a s 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 New Approach Notified and Designated Organisations (NANDO) database.