Presentation on theme: "APEC Conference Cuzco, Peru August 11, 2008 V.M. (Jim) DeLisi, Chairman SOCMAs International Trade Committee US Industries Experiences with REACh APEC."— Presentation transcript:
APEC Conference Cuzco, Peru August 11, 2008 V.M. (Jim) DeLisi, Chairman SOCMAs International Trade Committee US Industries Experiences with REACh APEC Conference Cuzco, Peru August 11, 2008 V.M. (Jim) DeLisi, Chairman SOCMAs International Trade Committee 1
SOCMA: History & Mission Synthetic Organic Chemical Manufacturers Association was founded in 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. 2
SOCMA: History & Mission Approx. 300 members Specialty, Batch & Contract chemical manufacturers Global membership Suppliers to the industry 80% small businesses < $50 million in annual sales < 200 employees Staff of 35 located in Washington, DC 3
SOCMA Members: Markets Served Pharmaceutical Fine Chemicals Cosmetics and Toiletries Personal Care Soaps and Detergents Industrial Products Construction Products Textiles 4 Household Products Agricultural Products Electronics/computers Food Performance Chemicals Plastics Petrochemicals
REACh Concerns & Experiences of our Members 5
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
7 7 ECHA registration fees OR & SIEF Participation fees Testing Costs Strict Liability IT upgrades to assure compliance Document Preparation Safety Assessment Technical Dossier 7 COSTS
Only Representative Cost Availability Accountability Independence One OR per foreign Manufacturer 8
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 9
Anti-Trust REACh compliance, if not done very carefully, could potentially involve a breach of U.S. Antitrust Laws! 10
Polymers Polymers can not be registered IPR Hazardous Monomers Very complex for Paints, Coatings, etc that can contain multiple polymers 11
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. 12
Pharmaceuticals Definition of the word INfor 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 13
Cosmetics Lack of EINECS and/or ELINCS numbers has already caused disruptions 14
Product Substitution and Withdrawals Will impact US Production Domestic sales Export sales Will have consequences for worldwide demand. 15
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! 16
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. 17
Domestic Dilemma #1 Ive got $1 M in sales in the EU and I need to register 50 compounds.
Domestic Dilemma #2 Id abandon my sales in the EU but the plant across the street will no longer be able to purchase my chemicals if I dont continue to supply their EU facilities.
Domestic Dilemma #3 I dont have any exports to the EU but my most important customer is telling me if I dont comply with REACh he can no longer buy my products.
SOCMAs 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. 21