Market access requirements EU Engineering products Legislation August 2014

Centre for the Promotion of Imports from developing countries | August Legislation CE marking Liability for defective products REACH Nonyl phenols and ethoxylates RoHS II Type approval Wood packaging materials May influence: Design, materials used, substances used, labelling, packaging, tests you need to conduct, information you need to provide

Centre for the Promotion of Imports from developing countries | September Market access requirements combination of legislation & market demands

Centre for the Promotion of Imports from developing countries | September Market access requirements combination of legislation & market demands

Legislation EU legislation only deals with ‘problems’ within the EU The product marketed in the EU Use Disposal / waste / recycling The packaging For a manufacturer of parts or components the legislation may not be directly relevant However, since the buyer will pass down requirements to his suppliers, indirectly this legislation will be (very) relevant Centre for the Promotion of Imports from developing countries | August

6 CE marking Sign of a product’s compliance with EU legislation (e.g. safety, health, environmental protection requirements) Based on EC Directives Use of Harmonised standards (EN standards) to assess conformity Enables free movement of products throughout the European Economic Area (EEA – the 28 Member States of the EU and EFTA countries, Iceland, Norway, Liechtenstein)

Centre for the Promotion of Imports from developing countries | August CE marking CE marking is only relevant for products placed on the European market Most manufacturers of parts and components do not need CE marking! However: You may have to provide technical documentation about components to the product manufacturer E.g. info on the use of (harmonised) standards and test reports

Centre for the Promotion of Imports from developing countries | August CE marking Only for product categories subject to specific European directives Products for professionals (e.g. medical devices, lifts, machinery and measuring equipment) and consumers (toys, PCs, mobile phones and light bulbs) checks/tests required to ensure the conformity of the product are carried out only by the manufacturer Importers must make sure that the products they place on the market comply with the applicable requirements

Centre for the Promotion of Imports from developing countries | August

10 CE marking The manufacturer itself assesses conformity and affixes the CE marking Products with a relatively high potential impact: involvement of a Conformity Assessment Body The manufacturer is still responsible for compliance The use of harmonised technical (EN) standards ensures compliance

Centre for the Promotion of Imports from developing countries | August CE marking Look for your product: goods/cemarking/professionals/index_en.htm goods/cemarking/professionals/index_en.htm

Liability for defective products Centre for the Promotion of Imports from developing countries | August The EU legislation on product liability holds your EU client responsible for injuries caused by imported defective products. However, your EU client may pass on a claim filed by an injured EU consumer to you. ‘Defective’ may relate to poor quality, but also to (for example) instructions.

Centre for the Promotion of Imports from developing countries | August REACH Registration, Evaluation, Authorisation and Restriction of Chemical substances To improve the protection of human health and the environment Manufacturers and importers are required to gather information on the properties of their chemical substances, which will allow their safe handling, and to register the information in a central database run by the European Chemicals Agency (ECHA) European Chemicals Agency (ECHA)

REACH Summary (1) To protect health and the environment Substances are classified according to their risks Specific restrictions to Substances of Very High Concern (SVHC) Importers / producers need to know what substances are present in materials/components and in what concentration (> 0,1%w/w) Centre for the Promotion of Imports from developing countries | August

REACH Summary (2) Suppliers: need to provide information about substances in their materials need to demonstrate compliance to REACH may have to provide Full Material Declarations (FMD) You may have to get the specific data from your substances supplier (a paper trail of REACH declarations) Look for alternatives in case of SVHC (future prohibition)! REACH is updated every 6 months Centre for the Promotion of Imports from developing countries | August

Centre for the Promotion of Imports from developing countries | August REACH (Mixtures of) substances are subject to registration with ECHA, if they are exported to the EU. The actual requirements depend on the nature of the substance and if the volume is ≥ 1 ton per importer per year. Also: Substances or mixtures in containers Substances in articles which are intentionally released during their use (e.g. a fragrance in a scented eraser) If substances fall under the obligation to register, but are not registered they may not be placed on the EU market.

REACH Substances of very high concern (SVHC) If one of the SVHC placed on the candidate list is present in a product above a concentration of 0.1% (w/w) and the total amount of the substance present in all articles exceeds 1 tonne per year, the use of this substance has to be notified. Therefore EU importers are very keen on knowing if and which SVHC are present in the articles they buy. Centre for the Promotion of Imports from developing countries | August

REACH If a substance is on the candidate list of SVHC this is a sign that the substance is unwanted by the EU Such a SVHC may very well be prohibited in the future Look for alternatives in case of SVHC! REACH results in a supply chain trail of REACH related information and compliance documents REACH is updated every 6 months…. Centre for the Promotion of Imports from developing countries | August

REACH: example Philips 1.Pre registration of their own substances 2.Provision of info by components and product suppliers 3.Use of BOMcheck industry platform for standardised info on subdstances: for RoHS and REACH and Philips requirements 4.Full Material Declarations (FMD) encouraged Changes in REACH and other legislation are automaticaly processed Centre for the Promotion of Imports from developing countries | August

Centre for the Promotion of Imports from developing countries | August RoHS II Reduction of Hazardous Substances in Electrical and Electronic equipment Restrictions on the use of 4 heavy metals and 2 flame retardants All EE equipment, unless exempted according to the Directive RoHS II into force since January 2013 No adjustments needed for products new in RoHS II until 22 July 2019 (with some exceptions)

RoHS II Centre for the Promotion of Imports from developing countries | August

RoHS II Examples of parts that may contain these restricted substances: Paints PVC cables Solders Lamps and bulbs (lead and cadmium) Fluorescent lamps (mercury) Flame retardants in plastics (PBB, PBDE) Metal finishes (hexavalent chromium). Centre for the Promotion of Imports from developing countries | August

RoHS II The restrictions goes for each separate material in the product! Homogeneous materials: plastics, ceramics, glass, metals, alloys, paper, board, resins, coatings Industry is looking for alternatives, e.g. alternatives for lead in soldering Centre for the Promotion of Imports from developing countries | August

RoHS II New substances may be added to RoHS II periodically! CE Mark to show compliance with RoHS RoHS is complementary to REACH: exporters need to comply with both! Centre for the Promotion of Imports from developing countries | August

Type approval automotive parts Requirements regarding technical, safety and environmental standards for (parts of) motor vehicles and agricultural and forestry tractors All automotive parts and components have to be type approved before allowed to be placed on the EU market Involves COP, testing and certification Conformity of Production (COP) is a requirement for type-approval COP requirements are based on ISO 9000 and ISO TS/16949 CE marking is in some cases accepted as a means of compliance Centre for the Promotion of Imports from developing countries | August

Type approval automotive parts EC type-approval: An EU-certification laid down in EU legislation valid in European Economic Area (EEA) and Switzerland; UN/ECE type-approval: A UN certification and valid in contracting countries worldwide including the EU Centre for the Promotion of Imports from developing countries | August

Wood packaging materials (WPM) Examples of WPM: packing cases, boxes, crates, drums, pallets and box pallets). The requirements also apply to dunnage (wood used to wedge and support non-wood cargo) WPM must comply with the following sets of requirements: 1.Requirements that apply to all plants and plant products brought into the EU (e.g. certain pests or plants are restricted to enter the EU). 2.Requirements that specifically apply to WPM (including dunnage): e.g. wood treatment and wood marking Centre for the Promotion of Imports from developing countries | August

Wood packaging materials (WPM) Centre for the Promotion of Imports from developing countries | August Your WPM supplier should arrange for the treatment and mark

Other legislation EU countries may set additional market access requirements Check for your potential export countries! Use the CBI website Centre for the Promotion of Imports from developing countries | August

Centre for the Promotion of Imports from developing countries | August