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Centre for the Promotion of Imports from developing countries | August 2013
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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 2010
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Market access requirementscombination of legislation & market demands
Centre for the Promotion of Imports from developing countries | September 2010
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Market access requirementscombination of legislation & market demands
Legislation
EU legislation only deals with ‘problems’ within the EU
•The product marketed in the EUUseDisposal / 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
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Centre for the Promotion of Imports from developing countries | August 2013
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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
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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 2013
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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 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
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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
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CE marking
• Look for your product:http://ec.europa.eu/enterprise/policies/single-market-goods/cemarking/professionals/index_en.htm
Liability for defective products
Centre for the Promotion of Imports from developing countries | August 2013
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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
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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)
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 2013
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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 2013
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Centre for the Promotion of Imports from developing countries | August 2013
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REACH
(Mixtures of) substances are subject to registration withECHA, 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 2013
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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
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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 2013
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Centre for the Promotion of Imports from developing countries | August 2013
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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
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
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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 2013
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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
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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-approvalCOP 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
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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 2013
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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 (includingdunnage): e.g. wood treatment and wood marking
Centre for the Promotion of Imports from developing countries | August 2013
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Wood packaging materials (WPM)
Centre for the Promotion of Imports from developing countries | August 2013
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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 2013
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