Arch Chemicals, Inc.
1955 Lake Park Drive
Smyrna, GA 30080
DATE: October, 2008
SUBJECT: REACH Regulation; EC 1907/2006
Registration, Evaluation and Authorisation of Chemicals
Polymer Pre-registration Process (Ver. 1, Oct 08)
Interpretation of Art 6.3
The issue of pre-registration of polymers (via their component monomers) has been an area of concern over the last few months.
A recent ECHA interpretation of Art 6.3 (Appendix 1) contradicted the widespread industry view of the pre-registration process. This view was challenged strongly by CEFIC as it imposes an unnecessary burden at a very late stage in the pre-registration process. However, ECHA has not accepted these appeals and maintained its position.
This new interpretation has major implications on pre-registration requirements for all supply chains handling monomers and polymers, including Arch customers.
The key point of this interpretation is that importers and manufacturers of polymers in the EU cannot rely on the pre-registration of the monomers conducted by their suppliers. In order to be able to continue to market polymers in the EU prior to the full registration of the importer or manufacturer’s supplier, the importer or manufacturer must itself pre-register the monomer(s) and can then abandon such pre-registration when the supplier has completed its full registration. This applies regardless of whether the monomers/polymers are supplied from within the EU or are imported and covered by the pre-registrations of an Only Representative (OR).
The guidance with respect to non-polymer substances remains unchanged.
Extracts of dialogue between ECHA and DG Enterprise on this issue[1] are given in Appendix 2.
This new ruling significantly impacts on the ability of Arch’s polymer customers who are “downstream users” to rely on the Arch Only Representative. The situation is complex but it is Arch’s understanding that:
1) Businesses who export monomers (in an unreacted form) to the EU, can be covered by the Arch OR. However their customers who manufacture polymers must duplicate the pre-registrations.
2) Businesses who export polymers to the EU cannot rely on the Arch OR and must duplicate pre-registration. This may mean an OR needs to be hired.
NOTE: many Arch Polyol products are considered as polymers under REACH definitions.
3) Businesses who manufacture polymers outside the EU using Arch monomers and then export to the EU must duplicate pre-registrations. Again, an OR will need to be hired.
4) Businesses who export Arch substances to the EU which are not monomers or polymers are not affected by this latest ruling.
Given the complexity of supply chain operations, Arch cannot provide guidance to individual companies on the appropriate strategy to achieve compliance with this new interpretation from ECHA.
It is essential customers review their own operations to determine their duties under REACH.
This information supersedes previous REACH communications regarding OR and compliance issues for monomers and polymers.
If you have any questions regarding REACH, please contact your normal Arch representative or e-mail .
Further information and guidance on the REACH Regulation can be found on the ECHA website http://echa.europa.eu/home_en.asp.
Best Regards,
Dr Michael Ellwood
Senior Regulatory Manager
Hexagon House, P O Box 42
Blackley
Manchester
England M9 8ZS
Phone: 44-161-721-1495
Fax: 44-161-721-1506
Email:
Appendix 1
REACH Article 6.3
General obligation to register substances on their own or
in preparations
6.3. Any manufacturer or importer of a polymer shall submit a
registration to the Agency for the monomer substance(s) or any
other substance(s), that have not already been registered by an
actor up the supply chain, if both the following conditions are
met:
(a) the polymer consists of 2 % weight by weight (w/w) or
more of such monomer substance(s) or other substance(s) in
the form of monomeric units and chemically bound
substance(s);
(b) the total quantity of such monomer substance(s) or other
substance(s) makes up one tonne or more per year.
Appendix 2
ECHA response to clarification of Art 6.3
“We would like to clarify that Article 6.3 says:
Any manufacturer or importer of a polymer shall submit a registration to ECHA for the monomer substance(s) or any other substances that have not already been registered by an actor up the supply chain.
If registration has not been submitted by an actor up the supply chain, we recommend to pre-register any monomer or other substances, as this is a precondition to be able to benefit from the extended phase-in deadlines for registration and will keep companies on the safe side.
Only limited information referred to in Article 28 of REACH shall be submitted to ECHA for pre-registration.
The same approach has been taken for re-imported substances and also on the substances in articles (Article 7.6).”
DG Enterprise response to clarification of ECHA position
“It should be noted that the exemptions mentioned in your mail relate to substances that have been registered up the supply chain and not to substances which have been pre-registered.
The two terms are not synonymous in REACH.
As indicated in the REACH Guidance for Monomers and Polymers, section 3.2.1.1, the manufacturer or importer of a polymer will not need to register the monomer substance, or any other substance chemically bound to the polymer, if these have already been registered by the supplier or another actor up their supply chain. For most polymer manufacturers the situation will generally be that their monomers and other substances will eventually be registered by the suppliers of these substances but not necessarily before the end of the pre-registration period on 1 December 2008.
In this case, a polymer manufacturer who has not pre-registered the monomers or other substances could not manufacture, or use the polymer until three weeks after he or the monomer manufacturer has submitted a full registration dossier to ECHA. (for more details , see the Guidance on Data Sharing, section 3.7, also referred to below).
For this reason polymer manufacturers are advised to pre-register the monomers they use……..”
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[1] Presented at 3rd International Conference RAPRA, REACH, Antwerp 16th Sept 08