Market access requirements EU Engineering products

Legislation

August 2014

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

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Market access requirementscombination of legislation & market demands

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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

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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)

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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

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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

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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

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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

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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.

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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)

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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

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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.

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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….

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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

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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

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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).

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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

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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!

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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

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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

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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

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Wood packaging materials (WPM)

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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

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