19 Aug 2016
2016 Update to EU Product Safety Manual: “The Blue Guide”
On 26 July 2016, the European Commission published an updated version of the so-called “Blue Guide” in the EU’s Official Journal. The document, used by industry and competent authorities alike, is a guidance on the application of product-related directives and regulations for goods destined for the EU market. The Blue Guide applies to the EU Member States and also to Iceland, Liechtenstein and Norway as members of the European Economic Area (EEA). It additionally applies to Turkey in certain cases. As such, the “Blue Guide” is an important guidance for Hong Kong’s exporters of fast-moving consumer goods, sold to customers in any of the aforementioned regions or jurisdictions.
Union harmonisation legislation: It is important to bear in mind that the Blue Guide’s reach is extremely wide. The Blue Guide provides direction on how to approach the European Union’s process of creating common laws and standards across the internal EU market – this effort is referred to as ‘harmonisation’. The main way in which the EU exercises this harmonisation initiative is through “directives” and “regulations”, which serve as harmonisation legislation. Harmonisation legislation covers EU laws in several different areas of great interest to Hong Kong traders. Such areas include: the Restriction of Hazardous Substances (RoHS) Directive, Ecodesign, Safety of Toys, Electrical Safety, Electromagnetic Compatibility, Machinery, Medical Devices and Energy Labelling. The aforementioned are only some of the different EU laws covered by this guide.
Product coverage: The Blue Guide provides a useful tool for Hong Kong traders in that it helps to identify when exports begin to be subjected to EU legislation. The point at which EU harmonisation legislation begins to apply to a product is when the product is intended to be placed on the market (or put into service). A product still in the distribution chain outside of, but intended for, the EU falls under the obligations of harmonisation legislation. This includes newly manufactured products as well as any used and second-hand products from a third country being exported for placing on the market in the EU. So while EU harmonisation legislation applies to “finished products”, the term applies both to newly manufactured items and to components and spare parts recovered from an item previously identified as a “finished product”, even if it was manufactured before any relevant legislation became applicable.
Should Hong Kong traders change or overhaul a product in a way that its original performance, purpose or type has been altered, and it can be considered a “new product”, the person who carried out the changes becomes the “manufacturer” and is subject to all the manufacturer’s obligations. Among the most costly obligations would be the performance of risk assessments relevant for that product category, such as preparation of the technical documentation, drawing up an EU declaration of conformity and affixing the CE marking on the product.
The above mentioned requirements do not extend to products which have been repaired or exchanged (for example following a defect), without changing the original performance, purpose or type of the product. Such products do not need to undergo conformity assessment again, whether or not the original product was placed on the market before or after the relevant new legislation which has entered into force. This applies even if the product has been temporarily exported from the EU to a third country for genuine repair operations.
CE marking: The Blue Guide also provides useful insight into the EU’s CE marking. The CE marking indicates that the manufacturer has declared, on his sole responsibility, that the product is in conformity with the essential requirements of the applicable EU harmonisation legislation and that the relevant conformity assessment procedure has been fulfilled. As such, the CE marking is not a mark of origin but a mark that all essential requirements associated with the product have been fulfilled. This marking can be affixed to the product or to the product’s data plate. If that is not possible then it can be affixed to the packaging and/or accompanying documents. In the event that Hong Kong traders export products to multiple markets, a product can bear additional markings to the CE marking. A product which has both the CE marking and the American FCC mark is a ready example of permissible multiple markings. That being said, no other marking which could cause confusion, or reduce the visibility of the CE marking, should be affixed to the product.
As for responsibility, importers and distributors bear an important duty to ensure the CE marking’s accuracy. When a product is produced outside of the common market, and the manufacturer is not represented in the EEA, the importers are responsible for ensuring that products placed on the market comply with the applicable requirements and do not represent a risk to the public. The importer must verify that the manufacturer outside the EU/EEA has undertaken the necessary steps and that the documentation is available upon request. It would serve Hong Kong traders well to diligently select manufacturers, as the importer may become responsible for an incorrect CE marking application.
Online retail: Another area of significant change this year has been the effort to bring the Blue Guide up to date with modern sales techniques, particularly sales by online operators – a notable omission in previous drafts. In this regard, new language has been introduced to address explicitly how product-related legislation should apply in the context of online sales. This would be a timely update for Hong Kong traders expanding their operations online.
This new version of the “Blue Guide” confirms that products offered for sale online by retailers based outside of the EU will be considered “placed on the market” if the website is specifically targeted at the EU and the product in question has completed the manufacturing stage. Whether a website targets EU consumers will be decided on a case-by-case basis, but indicative factors include: whether an online operator delivers in the EU, accepts payment by EU consumers and uses EU languages. The Commission can make such a finding even though market surveillance authorities and customs can only undertake a physical compliance check when the product reaches customs in the EU.
Hong Kong traders exporting/selling any of the products covered by EU harmonisation legislation would be advised to examine the Blue Guide. For more details or to consult the guidance directly, please see the European Commission website, which hosts the Blue Guide.