27 Sept 2018
UK Makes Plans for Stand-alone Compliance of Products Regime; Publishes Technical Notice
The purpose of the UK government’s Notices is to set out relevant information in order to allow businesses and citizens understand what they would need to do in a “no deal” scenario. However, it recognises that until a Withdrawal Agreement is signed and ratified by both the UK and European Parliaments, there remains the possibility that the UK may leave the EU without a deal in March 2019.
The second series of Technical Notices, published on 13 September 2018, concerns a range of topics, including the labelling of products and product safety, data protection, environmental protection, the regulation of medicines and medical equipment, and travelling between the UK and the EU. This update will focus on the Technical Notice concerning the trading of goods which are currently regulated under the EU’s “New Approach” laws regarding labelling and the conformity assessment of products (the “Notice”).
The Notice sets out the future arrangements for the products which fall within the scope of the EU’s so-called “New Approach” including, toys, hazardous substances in electrical and electronic equipment, personal protective equipment, construction products, radio equipment and marine equipment. Hong Kong traders should refer to Annex A of the Notice, which sets out the full list of EU regulations and directives concerning goods which fall within the scope of the Notice.
Notably, the Notice does not cover the following areas: vehicle type approval, aerospace, pharmaceutical products, medical devices, chemicals and goods subject to national regulations (non-harmonised goods).
The EU’s “New Approach” to product certification has streamlined product approvals for a broad range of goods in order to facilitate trade within the EU internal market. The relevant EU legislation sets out the “essential requirements” which products must meet before being placed on the EU market and defines how products can be tested in order to prove that they conform with these requirements. The main ways which manufacturers can demonstrate conformity include: (i) self-declaration by the manufacturer that they have taken appropriate steps to ensure their product is compliant (for example, for most toys); (ii) assessment of the final product by an EU-accredited body (a “notified body”); or (iii) assessment of a product’s design or prototype by a notified body, followed by testing of either a sample of the final product or quality assurance of production processes.
Following assessment, a manufacturer must affix a “conformity marking”, most commonly the “CE” marking, which indicates that the product is in conformity with the applicable EU requirements. Where third party testing is necessitated, the relevant notified body affixes its four-digit identification number to the product.
However, should the UK leave the EU without a deal in March 2019, the above conformity system will no longer be applicable for goods placed on the UK market and the results of conformity assessments carried out by UK notified bodies will no longer be recognised in the EU. This means that products tested by a UK notified body will no longer be able to be placed on the EU market without being re-tested and re-marked by an EU-recognised notified body. Therefore, Hong Kong manufacturers whose products have been tested by a UK-based notified body will need to be re-tested by an EU-recognised notified body before being placed on the EU internal market. A list of EU-recognised notified bodies can be found on the NANDO database.
Alternatively, the Notice states that manufacturers should seek to arrange for their files to be transferred to an EU-recognised notified body to allow for certificates of conformity issued by a UK-based notified body to continue to be valid. Moreover, products where third-party testing is required would need to be re-marked with the new EU-recognised notified body’s number.
The Notice provides guidance on the assessment system which will operate in the UK for manufacturers who want to place goods on the UK market after March 2019.
Firstly, as regards the relevant product requirements, it is stated that existing standards used to demonstrate conformity with EU essential requirements will become UK “designated standards” which will demonstrate conformity with UK essential requirements. Thus, the new UK standards will be identical to the current EU standards.
Secondly, notified bodies based in the UK will be granted new UK “approved body” status and will assess products for the UK market against UK essential requirements.
Finally, following assessment, manufacturers will be required to affix a new UK conformity marking before placing a product on the UK market. However, crucially for Hong Kong manufacturers, the Notice stipulates that for a limited period, products meeting EU requirements can continue to be placed on the UK market without any need for re-testing or re-marking. The Notice states that sufficient notice will be given to businesses before this period ends.
Moreover, the UK government published a Technical Notice regarding the status of “responsible persons” in a “no deal” scenario. Such responsible persons have the capacity to carry out certain tasks under EU product legislation on behalf of businesses. As Hong Kong manufacturers may be aware, the appointment of a responsible person is mandatory in some product sectors (e.g. cosmetics) where a manufacturer is not based in an EU country. In its Technical Notice, the UK government clarifies that any UK-based responsible person will no longer be recognised under EU law, meaning that they will not be recognised as able to carry out tasks on the manufacturer’s behalf in the EU.
As regards the UK market, businesses with a responsible person based in an EU country will not be impacted in the short term. However, in the long term, responsible persons will need to be based in the UK to be recognised under UK law. Notably, this interim approach is not applicable to cosmetics, and therefore, responsible persons based in an EU country will no longer be recognised by the UK after March 2019 due to the importance of ensuring the safety of cosmetic products on the market.
In total, the UK government has published 53 Technical Notices concerning preparations for a “no deal” scenario. Eight of these Technical Notices concern the labelling of products and product safety, covering a range of issues including developing genetically modified organisms, the labelling of tobacco products and e-cigarettes, organic goods and the mutual recognition principle.
Please click on the following to find all Technical Notices published to date.