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Market access requirements EU Engineering products Legislation PowerPoint Presentation
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Market access requirements EU Engineering products Legislation

Market access requirements EU Engineering products Legislation

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Market access requirements EU Engineering products Legislation

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  1. Market access requirements EU Engineering productsLegislation • August 2014

  2. Legislation • CE marking • Liability for defective products • REACH • Nonylphenols and ethoxylates • RoHS II • Type approval • Wood packagingmaterials • 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 | August 2013

  3. Market access requirementscombination of legislation & market demands Centre for the Promotion of Imports from developing countries | September 2010

  4. Market access requirementscombination of legislation & market demands Centre for the Promotion of Imports from developing countries | September 2010

  5. 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 2013

  6. CE marking • Sign of a product’s compliance with EU legislation (e.g. safety, health, environmental protection requirements) • Based on EC DirectivesUse 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 2013

  7. 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 manufacturerE.g. info on the use of (harmonised) standards and test reports Centre for the Promotion of Imports from developing countries | August 2013

  8. CE marking • Onlyfor product categoriessubject to specific European directives • Products for professionals (e.g. medical devices, lifts, machinery and measuringequipment) and consumers (toys, PCs, mobile phones and light bulbs) • checks/testsrequiredto ensure the conformity of theproduct are carried out only by the manufacturer • Importers must make sure that the products they placeon the market comply with the applicable requirements Centre for the Promotion of Imports from developing countries | August 2013

  9. Centre for the Promotion of Imports from developing countries | August 2013

  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 BodyThe 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 2013

  11. CE marking • Look for your product:http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/professionals/index_en.htm Centre for the Promotion of Imports from developing countries | August 2013

  12. Liabilityfordefectiveproducts 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 2013

  13. REACH • Registration, Evaluation, Authorisation andRestriction 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) Centre for the Promotion of Imports from developing countries | August 2013

  14. REACH Summary (1) To protecthealth and the environment Substances are classifiedaccording to theirrisks Specificrestrictions to Substances of Very High Concern (SVHC) Importers / producers need to knowwhatsubstances are present in materials/components and in whatconcentration (> 0,1%w/w) Centre for the Promotion of Imports from developing countries | August 2013

  15. REACH Summary (2) Suppliers: need to provide informationaboutsubstances in theirmaterials need to demonstratecompliance to REACH may have to provide Full MaterialDeclarations (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 updatedevery 6 months Centre for the Promotion of Imports from developing countries | August 2013

  16. 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. Centre for the Promotion of Imports from developing countries | August 2013

  17. 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 2013

  18. 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 2013

  19. REACH: example Philips Pre registration of theirownsubstances Provision of info bycomponents and product suppliers Use of BOMcheckindustry platform forstandardised info onsubdstances: forRoHS and REACH and Philips requirements Full MaterialDeclarations (FMD) encouragedChanges in REACH and otherlegislation are automaticalyprocessed Centre for the Promotion of Imports from developing countries | August 2013

  20. 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) Centre for the Promotion of Imports from developing countries | August 2013

  21. RoHS II Centre for the Promotion of Imports from developing countries | August 2013

  22. 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 2013

  23. RoHS II The restrictionsgoesforeach separate materialin the product! Homogeneousmaterials: plastics, ceramics, glass, metals, alloys, paper, board, resins, coatings Industry is lookingforalternatives, e.g. alternativesforlead in soldering Centre for the Promotion of Imports from developing countries | August 2013

  24. 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 2013

  25. Type approvalautomotiveparts 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 2013

  26. Type approvalautomotiveparts 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 2013

  27. Wood packagingmaterials (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: 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). Requirements that specifically apply to WPM (includingdunnage): e.g. wood treatment and wood marking Centre for the Promotion of Imports from developing countries | August 2013

  28. Wood packagingmaterials (WPM) Your WPM supplier should arrange for the treatment and mark Centre for the Promotion of Imports from developing countries | August 2013

  29. Otherlegislation 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 2013

  30. Centre for the Promotion of Imports from developing countries | August 2013