2. General Principles
• A substance manufacturer located outside the EU has
no direct EU REACH obligations.
• That manufacturer cannot pre-register or register.
• REACH compliance is the responsibility of the EU-
based importer (note: importer as defined in REACH).
• The non-EU manufacturer can sell to the EU without
regard for his EU customer’s REACH compliance (i.e.
there is no obligation to confirm that the EU importer
has fulfilled his REACH obligations).
3. Strategy
There is one important question that the non-EU
manufacturer should answer, namely:
How important is the EU market to me now,
and in the future?
4. Options for non-EU manufacturer
1. The EU market is not important (i.e. opportunistic or
infrequent sales to the EU)
Option:
EU REACH can be ignored. The non-EU manufacturer can
sell to whoever wishes to purchase with consideration
only to normal contractual terms and conditions of sale
(REACH obligations shall lie with the EU-based importer).
5. Options
2. EU market is important (i.e. customer support for
REACH is an important, long-term strategy).
Actions:
The non-EU manufacturer then has 3 options:-
1. Help each EU-based customer to register itself as
importer (note this will then allow customer to import
the same substance from any non-EU manufacturer)
2. Establish own legal entity in the EU to import, REACH
register and supply to EU-based customers
3. Nominate a REACH ‘only representative’ (OR)
6. Only representative - the process
• Non-EU manufacturer decides to appoint an OR and
an agreement between that manufacturer and the OR
is established.
• Manufacturer writes to its EU-based importers to
inform of the existence of an OR and gives full details
of OR and substance/s covered by the agreement.
• Importantly, those EU importers of the substance
become downstream users of that OR
• OR fulfills REACH obligations that would normally fall
to those named EU-based importers*
*Importantly, the OR does not register on behalf of the non-EU manufacturer
7. Only Representative (OR)
An OR does not assume the obligations of the non-EU
manufacturer (there is none); rather, the OR takes on the
REACH obligations of the EU-based importer/s from that
non-EU manufacturer.
The EU importers become downstream users of the
OR for the named substance that they import from the
Identified non-EU manufacturer.
OR can be nominated by multiple non-EU manufacturers
8. However…
A cautionary note :
Whilst a non-EU manufacturer has no direct REACH
obligations and no requirement to check his EU
importer’s REACH compliance, that EU-based importer
may be forced to cease or suspend importing if he does
not comply with REACH obligations (e.g. following
enforcement action).
A check of REACH compliance down the supply chain,
whilst not mandatory, may be prudent in the interests of
business continuity
9. OR: myth vs reality for a non-EU manufacturer
Myth Reality
1. A non-EU manufacture must 1. Options exist, including doing
appoint an OR nothing
2. An OR registers on behalf of 2. The OR registers in his own right.
the non-EU manufacturer 3. The OR assumes the REACH
3. The OR registers on behalf of obligations of EU importers.
the non-EU manufacturer 4. Any natural or legal person
4. The OR must also be my EU established in the EU can be an OR
sales office or agent 5. Exiting commercial channels can be
5. I must sell through the OR maintained. The OR role is for EU
6. I can only sell to REACH- importer’s REACH compliance
registered EU importers 6. You can sell to whoever you wish.
10. Summary
• A non-EU manufacturer has no REACH obligations
• If the EU market is important, consideration should be
given to a long-term REACH strategy
• The OR route is not mandatory. There are a number of
options available to the non-EU manufacturer
• If an OR is nominated, he registers in his own right and
assumes REACH obligations in his own right
• EU-based importers become downstream users (DU)
of the OR
• The same OR can me nominated by multiple non-EU
manufacturers (good record keeping needed)