Market access
requirements EU
Engineering products
Legislation
August 2014
Legislation
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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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Centre for the Promotion of Imports from developing
countries | August 2013
Market access requirements
combination of legislation & market demands
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Centre for the Promotion of Imports from developing
countries | September 2010
Market access requirements
combination of legislation & market demands
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Centre for the Promotion of Imports from developing
countries | September 2010
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
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Centre for the Promotion of Imports from developing
countries | August 2013
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)
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Centre for the Promotion of Imports from developing
countries | August 2013
CE marking
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CE marking is only relevant for products placed on the
European market
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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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Centre for the Promotion of Imports from developing
countries | August 2013
CE marking
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Only for product categories subject to specific
European directives
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Products for professionals (e.g. medical devices, lifts,
machinery and measuring equipment)
and consumers (toys, PCs, mobile phones and light bulbs)
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checks/tests required to ensure the conformity of the
product are carried out only by the manufacturer
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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 2013
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Centre for the Promotion of Imports from developing
countries | August 2013
CE marking
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The manufacturer itself assesses conformity and affixes
the CE marking
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Products with a relatively high potential impact:
involvement of a Conformity Assessment Body
The manufacturer is still responsible for compliance
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The use of harmonised technical (EN) standards ensures
compliance
Centre for the Promotion of Imports from developing
countries | August 2013
CE marking
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Look for your product:
http://ec.europa.eu/enterprise/policies/single-marketgoods/cemarking/professionals/index_en.htm
Centre for the Promotion of Imports from developing
countries | August 2013
Liability for defective products
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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Centre for the Promotion of Imports from developing
countries | August 2013
REACH
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Registration, Evaluation, Authorisation and
Restriction of Chemical substances
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To improve the protection of human health and the
environment
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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
REACH
Summary (1)
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To protect health and the environment
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Substances are classified according to their risks
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Specific restrictions to Substances of Very High Concern (SVHC)
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Importers / producers need to know what substances are present in
materials/components and in what concentration (> 0,1%w/w)
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Centre for the Promotion of Imports from developing
countries | August 2013
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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Centre for the Promotion of Imports from developing
countries | August 2013
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:
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Substances or mixtures in containers
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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.
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Centre for the Promotion of Imports from developing
countries | August 2013
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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Centre for the Promotion of Imports from developing
countries | August 2013
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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Centre for the Promotion of Imports from developing
countries | August 2013
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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Centre for the Promotion of Imports from developing
countries | August 2013
RoHS II
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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
RoHS II
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Centre for the Promotion of Imports from developing
countries | August 2013
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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Centre for the Promotion of Imports from developing
countries | August 2013
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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Centre for the Promotion of Imports from developing
countries | August 2013
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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Centre for the Promotion of Imports from developing
countries | August 2013
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
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Centre for the Promotion of Imports from developing
countries | August 2013
Type approval automotive parts
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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
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
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Centre for the Promotion of Imports from developing
countries | August 2013
Wood packaging materials (WPM)
Your WPM supplier should arrange
for the treatment and mark
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Centre for the Promotion of Imports from developing
countries | August 2013
Other legislation
EU countries may set additional market access requirements
Check for your potential export
countries!
Use the CBI website
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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