Download - SOCMA: History & Mission
US Industries Experiences with REAChAPEC ConferenceAPEC Conference
Cuzco, PeruCuzco, PeruAugust 11, 2008August 11, 2008
V.M. (Jim) DeLisi, ChairmanV.M. (Jim) DeLisi, ChairmanSOCMA’s International Trade CommitteeSOCMA’s International Trade Committee
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SOCMA: History & MissionSynthetic Organic Chemical Manufacturers
Association was founded in 1921. Since then, SOCMA has:•Spoken for and served batch, custom and small
chemical companies. •Promoted innovative, safe and environmentally
responsible operations.• Is a recognized and respected voice in
Washington, D.C.
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SOCMA: History & MissionApprox. 300 members
Specialty, Batch & Contract chemical manufacturersGlobal membershipSuppliers to the industry80% small businesses
• < $50 million in annual sales• < 200 employees
Staff of 35 located in Washington, DC
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SOCMA Members: Markets Served
Pharmaceutical Fine ChemicalsCosmetics and ToiletriesPersonal CareSoaps and DetergentsIndustrial ProductsConstruction ProductsTextiles
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Household ProductsAgricultural ProductsElectronics/computersFoodPerformance ChemicalsPlasticsPetrochemicals
REACh Concerns & Experiences
of our Members
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•The implementing rules are still in transition. It is not a completed regulation.•Can ECHA, a brand new agency, effectively administer this complicated regulation?
• The fact that IUCLID 5 has had a rocky start is not a good sign!
• US EPA has been skeptical that this rule can be effectively administered 6
Macro Concerns
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•ECHA registration fees•“OR” & SIEF Participation fees•Testing Costs•Strict Liability•“IT “ upgrades to assure compliance•Document Preparation
• Safety Assessment• Technical Dossier
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COSTS
Only Representative• Cost• Availability• Accountability• Independence• One “OR” per foreign Manufacturer
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Intellectual Property Rights• Non Biocidal uses of Biocides• Additives
• Non-hazardous additives below 1% are not listed on our MSD sheets – may have to be disclosed under REACh.
• Confidential Formula may have to be disclosed.• Unique “Identifiers” – how will they be used?• SIEF participation
• One substance – one registration
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Anti-Trust
REACh compliance, if not done very carefully, could
potentially involve a breach of U.S. Antitrust Laws!
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Polymers•Polymers can not be registered
•IPR•“Hazardous Monomers”•Very complex for Paints, Coatings, etc
that can contain multiple polymers
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US Based Trading Companies
• Non EU based traders can not register without the permission of the manufacturer:
• A non-EU based trader must partner with the manufacturer of materials destine for the EU – can be both an IP and contracting problem since a non-EU manufacturer can only work through one “OR”.
• Those with EU platform may change the way they invoice customers to allow their EU company to invoice – reducing US income – and the taxes it generates.
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Pharmaceuticals• Definition of the word “IN”for
Intermediates• Confusion: Do sole pharmaceutical use
intermediates need to be registered? If so, the lack of EINECS or ELINCS numbers for many will cause disruptions
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CosmeticsLack of EINECS and/or ELINCS numbers has
already caused disruptions
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Product Substitution and Withdrawals
• Will impact US Production•Domestic sales•Export sales
• Will have consequences for worldwide demand.
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Intra-company Transfers• Much of US/EU trade in Chemicals is Inter-
Company transfers.• Products manufactured in the EU but not consumed
in the EU are covered by REACh. This was not the case with EINECS or ELINCS (or TSCA).
• May encourage big companies to alter their invoicing patterns resulting in reduced US sales.
• IT challenge is enormous!
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Candidates List•Creates a “banned” list of substances without the need for sound science.•May take decades to review.•May “force” substitution with untested materials.
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Domestic Dilemma #1I’ve got $1 M in sales in
the EU and I need to register 50
compounds.
Domestic Dilemma #2I’d abandon my sales in the EU but the plant across the street
will no longer be able to purchase my chemicals if I
don’t continue to supply their EU facilities.
Domestic Dilemma #3
I don’t have any exports to the EU but my most important
customer is telling me if I don’t comply with REACh he can no
longer buy my products.
SOCMA’s Role• Support our membership with seminars and advice.
• INFORMEX 2009 in January• Webinars• Expert Advice• Consortium formation
• Recommended Partners• Work to avoid the spread of REACh like regulations, especially
into the USA.
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