Under the REACH regulations, everyone has been eager to see what the SVHC substances will be. Here is the proposed SVHC 16 that was just released:
The proposal includes the following 16 substances:
- Anthracene - 4,4'
- Diaminodiphenylmeth ane
- Dibutyl phthalate
- Cyclododecane
- Cobalt dichloride
- Diarsenic pentaoxide
- Diarsenic trioxide
- Sodium dichromate, dihydrate
- 5-tert-butyl- 2,4,6-trinitro- m-xylene (musk xylene)
- Bis (2-ethyl(hexyl) phthalate) (DEHP)
- Hexabromocyclododec ane (HBCDD)
- Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins)
- Bis(tributyltin) oxide
- Lead hydrogen arsenate
- Triethyl arsenate
- Benzyl butyl phthalate
More information about the Proposed Candidates List is located here:
http://echa. europa.eu/ consultations/ authorisation/ svhc/svhc_ cons_en.asp
Click on 'Link to the Annex XV report' for details on each substance.
Once the list is finalized and in effect, Authorization will be required if companies use these substances.
Wednesday, July 2, 2008
Tuesday, April 22, 2008
REACHtracker
SaaS solution facilitates identification and management of supplier substance pre-registration and registration intentions under REACH legislation
Boston, Massachusetts, April 23, 2008—Actio in partnership with Atrion International today announced the availability of REACHtrackerTM, a SaaS solution for managing supply chain communication and substance inventory for pre-registration and registration obligations under Europe’s new REACH legislation. REACHtrackerTM enables companies to initiate supply chain cooperation by leveraging structured e-mail communications and secure on-line questionnaires that facilitate the otherwise complex, time-consuming process of gathering and managing supplier substance registration intentions—the critical first step towards REACH compliance.
“REACH poses significant supply chain risk for companies selling products and raw materials into and within the EU,” stated Russ McCann, Actio’s President. “If a company is unaware of the registration status of their raw materials, they could face manufacturing disruption or worse, prohibition. REACHtrackerTM eliminates this risk by providing a collaborative environment to capture substance data and REACH intentions, on an ongoing basis, throughout the supply chain.”
REACHtrackerTM enables companies to build email campaigns that direct suppliers to enter substance information and declare their REACH registration intentions via a secure on-line questionnaire that links directly into a substance information management database. The progress of each supplier can be tracked and follow-up e-mail campaigns can be conducted for non-responsive suppliers. REACHtrackerTM also provides a dashboard to manage supplier contact information, as well as sophisticated parametric reporting tools that enable data to be rolled up into an unlimited number of custom reports. Once all substance information is collected, REACHtrackerTM automatically generates and uploads pre-registration XML files.
“Atrion is very pleased to have been able to continue the collaborative nature of our partnership with Actio,” said Patrick Lavoie, President at Atrion. “By providing Atrion’s regulatory insight and market validation, REACHtrackerTM is a viable REACH solution for companies facing the complexities of the European Union’s REACH Legislation.”
REACHtrackerTM fully supports Verisign’s Secure Socket Layer (SSL) to ensure security of data flow throughout the supply chain. The solution is also fully integrated with Actio’s Chemical Management Solutions enabling the automatic pre-screening and authorization of new chemicals, (M)SDS management, inventory tracking using ERP systems, storage and dissemination of raw material information.
REACHtrackerTM is currently available in both the North American and European Union and is co-marketed by both Actio and Atrion International.
About REACH
REACH is a substance-based regulation which mandates that every substance used in the manufacture of an article or preparation needs be identified and assessed. If greater than one ton is purchased or used, then the material must be registered with the European Chemicals Agency (ECHA). REACH obligations correlate directly to a company’s REACH role within the supply chain. Typically a substance manufacturer would register the chemical so the downstream users can continue to use the substances in their products. If for example, a supplier chooses not to register a particular substance, then the downstream customer must either register the substance itself or discontinue use of the substance. The deadline for pre-registration is December 1st 2008.
About Actio Corporation
Since 1996, Actio has been helping companies and millions of their employees, in a wide range of industries, cost-effectively manage the complexities surrounding the use of chemicals in the global workplace. Actio is a leading provider of chemical management solutions delivered as SaaS (software as a service). Our chemical management portfolio manages all phases of the chemical life cycle, enabling corporations to utilize Six Sigma or a “best practices” approach for chemical management. Actio solutions track raw material chemical composition for compliance with global regulations including: REACH, RoHS, WEEE. For more information about Actio Corporation, visit www.actiocms.com
About Atrion
Atrion International Inc., founded in 1989, delivers the most reliable and dependable product compliance solutions for multi-national ‘formula-based’ companies. Compared to other solutions, Atrion integrates the largest set of ‘expert’ regulatory content into a proven & pre-packaged automation solution. Able to ‘connect’ to key ERP systems, Atrion’s material compliance solution delivers the peace of mind that products will reach customers, with minimal risks to brand image and shareholder value. Additionally, Atrion and its certified SAP® partners provide a robust solution which compliments SAP’s REACH offering. Atrion International is a global software company headquartered in Montreal, Quebec, Canada with offices in the United States, Europe and Asia Pacific.
Boston, Massachusetts, April 23, 2008—Actio in partnership with Atrion International today announced the availability of REACHtrackerTM, a SaaS solution for managing supply chain communication and substance inventory for pre-registration and registration obligations under Europe’s new REACH legislation. REACHtrackerTM enables companies to initiate supply chain cooperation by leveraging structured e-mail communications and secure on-line questionnaires that facilitate the otherwise complex, time-consuming process of gathering and managing supplier substance registration intentions—the critical first step towards REACH compliance.
“REACH poses significant supply chain risk for companies selling products and raw materials into and within the EU,” stated Russ McCann, Actio’s President. “If a company is unaware of the registration status of their raw materials, they could face manufacturing disruption or worse, prohibition. REACHtrackerTM eliminates this risk by providing a collaborative environment to capture substance data and REACH intentions, on an ongoing basis, throughout the supply chain.”
REACHtrackerTM enables companies to build email campaigns that direct suppliers to enter substance information and declare their REACH registration intentions via a secure on-line questionnaire that links directly into a substance information management database. The progress of each supplier can be tracked and follow-up e-mail campaigns can be conducted for non-responsive suppliers. REACHtrackerTM also provides a dashboard to manage supplier contact information, as well as sophisticated parametric reporting tools that enable data to be rolled up into an unlimited number of custom reports. Once all substance information is collected, REACHtrackerTM automatically generates and uploads pre-registration XML files.
“Atrion is very pleased to have been able to continue the collaborative nature of our partnership with Actio,” said Patrick Lavoie, President at Atrion. “By providing Atrion’s regulatory insight and market validation, REACHtrackerTM is a viable REACH solution for companies facing the complexities of the European Union’s REACH Legislation.”
REACHtrackerTM fully supports Verisign’s Secure Socket Layer (SSL) to ensure security of data flow throughout the supply chain. The solution is also fully integrated with Actio’s Chemical Management Solutions enabling the automatic pre-screening and authorization of new chemicals, (M)SDS management, inventory tracking using ERP systems, storage and dissemination of raw material information.
REACHtrackerTM is currently available in both the North American and European Union and is co-marketed by both Actio and Atrion International.
About REACH
REACH is a substance-based regulation which mandates that every substance used in the manufacture of an article or preparation needs be identified and assessed. If greater than one ton is purchased or used, then the material must be registered with the European Chemicals Agency (ECHA). REACH obligations correlate directly to a company’s REACH role within the supply chain. Typically a substance manufacturer would register the chemical so the downstream users can continue to use the substances in their products. If for example, a supplier chooses not to register a particular substance, then the downstream customer must either register the substance itself or discontinue use of the substance. The deadline for pre-registration is December 1st 2008.
About Actio Corporation
Since 1996, Actio has been helping companies and millions of their employees, in a wide range of industries, cost-effectively manage the complexities surrounding the use of chemicals in the global workplace. Actio is a leading provider of chemical management solutions delivered as SaaS (software as a service). Our chemical management portfolio manages all phases of the chemical life cycle, enabling corporations to utilize Six Sigma or a “best practices” approach for chemical management. Actio solutions track raw material chemical composition for compliance with global regulations including: REACH, RoHS, WEEE. For more information about Actio Corporation, visit www.actiocms.com
About Atrion
Atrion International Inc., founded in 1989, delivers the most reliable and dependable product compliance solutions for multi-national ‘formula-based’ companies. Compared to other solutions, Atrion integrates the largest set of ‘expert’ regulatory content into a proven & pre-packaged automation solution. Able to ‘connect’ to key ERP systems, Atrion’s material compliance solution delivers the peace of mind that products will reach customers, with minimal risks to brand image and shareholder value. Additionally, Atrion and its certified SAP® partners provide a robust solution which compliments SAP’s REACH offering. Atrion International is a global software company headquartered in Montreal, Quebec, Canada with offices in the United States, Europe and Asia Pacific.
Tuesday, March 25, 2008
North American Companies in Jeopardy of Missing REACH Deadline
Despite a November 30 deadline, business leaders appear lax about taking steps to comply with the Registration, Evaluation and Authorization of Chemicals legislation, or REACH, according to a survey released March 11 by PricewaterhouseCoopers, titled “Waking up to REACH.” Two-thirds of North American organizations have limited knowledge of the operational impacts the European Union (EU) legislation could have on their business. There is also concern that North American companies will miss important REACH deadlines, consequently suffering significant business disruptions.
The clock begins ticking on June 1 for companies to begin REACH pre-registration, which provides manufacturers and exporters of chemicals to Europe six months to complete the process. In anticipation of this looming deadline, PricewaterhouseCoopers surveyed 241 senior executives across six industries in 29 countries to gauge readiness and reaction to REACH. The survey shows that two in five companies appear to have limited awareness of the regulation and one in four executives feels Europe’s newest rules on chemicals and their safe use will have no impact on their business.
REACH became law on June 1, 2007, to streamline and improve the former legislative framework on chemicals in the EU. REACH places greater responsibility on the industry to manage the risks that chemicals may pose to health and the environment. It applies to all chemicals – those used in industrial processes as well as in products such as cleansers, paints and appliances – meaning upstream and downstream in the chemicals supply chain.
“REACH ensures that the industry maintains some accountability in improving the protection of human health and the environment from the risks that can be posed by chemicals,” said Saverio Fato, global leader of PricewaterhouseCoopers Chemicals practice. “That being said, U.S. companies that are facing these new regulations do not appear to be on track for compliance, which may lead to operational problems down the line.”
Large companies have greater awareness of the legislation than smaller ones and the survey found that European companies are best prepared for REACH, as they are most aware of the legislation. Among industries, chemical companies lead the way on awareness followed by pharmaceuticals; industrial manufacturing; forest, paper and packaging; retail and consumer; and automotive.
The survey found that not only is REACH awareness low among North American companies, but most survey respondents had not discussed the European law with customers or suppliers to determine the impact on their supply chains. In comparison, half of European companies surveyed said they’ve initiated contact with suppliers concerning REACH.
This apparent lack of action to contact suppliers and engage in discussions with downstream companies and customers could negatively affect business. The European Chemicals Agency (ECHA) estimates between 10 percent and 30 percent of classified chemicals that are listed with the ECHA will disappear as a result of REACH. Early communication with downstream companies and suppliers, whose businesses may be adversely impacted by the disappearance of these substances, is essential to maintain supply chains.
Most organizations said they have not yet completed risk assessments on how REACH will impact their businesses. Only 10 percent had completed a detailed assessment, 30 percent completed some risk assessment and 31 percent had no risk assessment. North American and Asia-Pacific companies are the worst offenders in terms of not carrying out the necessary level of risk assessment to measure the impact of the REACH legislation.
Those executives surveyed who are in the know about REACH said there would be risks to implementing the law. Most (54 percent) cited the cost and time involved, followed closely by supplier risk (49 percent). Only 14 percent of executives surveyed feel REACH will have a positive impact on their businesses; the majority is withholding judgment until the legislation goes into effect.
When asked what action companies were most likely to take as a result of the REACH legislation, an overwhelming 66 percent said they were ensuring suppliers adhere to REACH compliance deadlines, otherwise known as supply chain assurance. Another 46 percent said they would take action to help suppliers comply with REACH, and 45 percent said the legislation would require them to renegotiate or modify their supplier contracts.
“While an 11-year timeline to register chemicals may seem like a long time, it will certainly be a huge undertaking to register the 30,000 or so existing chemicals for REACH compliance. Only those companies that meet pre-registration deadlines for REACH will truly capitalize on the legislation. This includes continuing to operate business as usual and qualifying for an extended timeline to register existing substances used in the European market,” said Fato.
“The pre-registration process is not very time-consuming, but it is required in order for companies to secure access to the EU market,” added Dr. Hans Schoolderman, director of sustainability and climate change services for PricewaterhouseCoopers. “If handled properly, the legislation can enhance the bottom line by increasing the customer confidence in product safety. Consumers have little to no tolerance for chemicals that are a risk to human health and the environment. It is good practice and good governance for companies to be transparent to their customers regarding their products and the safe use of the products – and REACH will help get us there.”
For more information and to access the full report, visit: www.pwc.com/chemicals.
The clock begins ticking on June 1 for companies to begin REACH pre-registration, which provides manufacturers and exporters of chemicals to Europe six months to complete the process. In anticipation of this looming deadline, PricewaterhouseCoopers surveyed 241 senior executives across six industries in 29 countries to gauge readiness and reaction to REACH. The survey shows that two in five companies appear to have limited awareness of the regulation and one in four executives feels Europe’s newest rules on chemicals and their safe use will have no impact on their business.
REACH became law on June 1, 2007, to streamline and improve the former legislative framework on chemicals in the EU. REACH places greater responsibility on the industry to manage the risks that chemicals may pose to health and the environment. It applies to all chemicals – those used in industrial processes as well as in products such as cleansers, paints and appliances – meaning upstream and downstream in the chemicals supply chain.
“REACH ensures that the industry maintains some accountability in improving the protection of human health and the environment from the risks that can be posed by chemicals,” said Saverio Fato, global leader of PricewaterhouseCoopers Chemicals practice. “That being said, U.S. companies that are facing these new regulations do not appear to be on track for compliance, which may lead to operational problems down the line.”
Large companies have greater awareness of the legislation than smaller ones and the survey found that European companies are best prepared for REACH, as they are most aware of the legislation. Among industries, chemical companies lead the way on awareness followed by pharmaceuticals; industrial manufacturing; forest, paper and packaging; retail and consumer; and automotive.
The survey found that not only is REACH awareness low among North American companies, but most survey respondents had not discussed the European law with customers or suppliers to determine the impact on their supply chains. In comparison, half of European companies surveyed said they’ve initiated contact with suppliers concerning REACH.
This apparent lack of action to contact suppliers and engage in discussions with downstream companies and customers could negatively affect business. The European Chemicals Agency (ECHA) estimates between 10 percent and 30 percent of classified chemicals that are listed with the ECHA will disappear as a result of REACH. Early communication with downstream companies and suppliers, whose businesses may be adversely impacted by the disappearance of these substances, is essential to maintain supply chains.
Most organizations said they have not yet completed risk assessments on how REACH will impact their businesses. Only 10 percent had completed a detailed assessment, 30 percent completed some risk assessment and 31 percent had no risk assessment. North American and Asia-Pacific companies are the worst offenders in terms of not carrying out the necessary level of risk assessment to measure the impact of the REACH legislation.
Those executives surveyed who are in the know about REACH said there would be risks to implementing the law. Most (54 percent) cited the cost and time involved, followed closely by supplier risk (49 percent). Only 14 percent of executives surveyed feel REACH will have a positive impact on their businesses; the majority is withholding judgment until the legislation goes into effect.
When asked what action companies were most likely to take as a result of the REACH legislation, an overwhelming 66 percent said they were ensuring suppliers adhere to REACH compliance deadlines, otherwise known as supply chain assurance. Another 46 percent said they would take action to help suppliers comply with REACH, and 45 percent said the legislation would require them to renegotiate or modify their supplier contracts.
“While an 11-year timeline to register chemicals may seem like a long time, it will certainly be a huge undertaking to register the 30,000 or so existing chemicals for REACH compliance. Only those companies that meet pre-registration deadlines for REACH will truly capitalize on the legislation. This includes continuing to operate business as usual and qualifying for an extended timeline to register existing substances used in the European market,” said Fato.
“The pre-registration process is not very time-consuming, but it is required in order for companies to secure access to the EU market,” added Dr. Hans Schoolderman, director of sustainability and climate change services for PricewaterhouseCoopers. “If handled properly, the legislation can enhance the bottom line by increasing the customer confidence in product safety. Consumers have little to no tolerance for chemicals that are a risk to human health and the environment. It is good practice and good governance for companies to be transparent to their customers regarding their products and the safe use of the products – and REACH will help get us there.”
For more information and to access the full report, visit: www.pwc.com/chemicals.
Friday, March 14, 2008
Awareness of REACH is Low
Global companies weigh risks and rewards of Europe's newest law on the safe use of chemicals
Despite a November 30 deadline for taking steps to comply, our ‘Waking up to REACH*' shows awareness of REACH is low, especially outside Europe and the chemicals industry. Failure to meet the terms of this European regulation could lead to a ban on exports to the EU and is a growing concern to EU-based companies.
241 senior executives across six industries in 29 countries were interviewed on gauge readiness and reaction to REACH. Download the full report here.
Despite a November 30 deadline for taking steps to comply, our ‘Waking up to REACH*' shows awareness of REACH is low, especially outside Europe and the chemicals industry. Failure to meet the terms of this European regulation could lead to a ban on exports to the EU and is a growing concern to EU-based companies.
241 senior executives across six industries in 29 countries were interviewed on gauge readiness and reaction to REACH. Download the full report here.
Wednesday, March 5, 2008
SMEs Facing Big Challenge with REACH
Whether manufacturers, importers, downstream users or distributors, small and medium-sized enterprises (SMEs) doing business in Europe must comply with Reach regulations. Even if a company produces less than the 1 tonne/year lower limit for registration, Kline & Company recommends that SME's preregister products. In doing so they become part of a Substance Information Exchange Forum (SIEF) that includes companies registering the same chemical substance, making it possible for members to share data and costs.
Without in-house expertise and the necessary financial resources, many SMEs will find registration costs uneconomical and may no longer offer certain products in the European market. Those that are downstream users may be left searching for new suppliers or substitutes for key raw materials if their suppliers don't register these materials.
The act of preregistering does not mean that a company must ultimately register a product. But it does give SMEs an opportunity to see who else is in the SIEFs for certain compounds and "opens up strategic opportunities for SMEs to divest product lines, purchase new lines, or even acquire competing companies," according to Kline. Also, any chemical substance with an annual volume of greater than 1 tonne/year not preregistered during June 1 to November 30, 2008 will be banned from production or marketing in the EU as of December 1.
Separately, Indian chemical industry officials have conservatively estimated that the country could lose as much as $2.2 billion (Euro 1.5 billion) in trade if companies in the country elect not to comply with Reach and therefore cannot trade with the EU. Compliance with Reach is very expensive, according to one trader, and definitely will have an impact on profits. But many in India believe that companies will preregister so that they can continue to do business with Europe.
Without in-house expertise and the necessary financial resources, many SMEs will find registration costs uneconomical and may no longer offer certain products in the European market. Those that are downstream users may be left searching for new suppliers or substitutes for key raw materials if their suppliers don't register these materials.
The act of preregistering does not mean that a company must ultimately register a product. But it does give SMEs an opportunity to see who else is in the SIEFs for certain compounds and "opens up strategic opportunities for SMEs to divest product lines, purchase new lines, or even acquire competing companies," according to Kline. Also, any chemical substance with an annual volume of greater than 1 tonne/year not preregistered during June 1 to November 30, 2008 will be banned from production or marketing in the EU as of December 1.
Separately, Indian chemical industry officials have conservatively estimated that the country could lose as much as $2.2 billion (Euro 1.5 billion) in trade if companies in the country elect not to comply with Reach and therefore cannot trade with the EU. Compliance with Reach is very expensive, according to one trader, and definitely will have an impact on profits. But many in India believe that companies will preregister so that they can continue to do business with Europe.
Monday, March 3, 2008
Changes in EU Cosmetic Laws
A proposed new regulation intended to replace the existing EU Cosmetics Directive (76/768/EEC) has been published following a period of consultation. The document, still very much in draft form, can be viewed at:
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0049:FIN:EN:PDF
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=COM:2008:0049:FIN:EN:PDF
Tuesday, February 26, 2008
REACH Workshop - 14 April 2008
Final Countdown to Pre-Registration and Registration of Chemicals:
The workshop aims to alert companies that they should not miss the pre-registration "window". It will explain the key elements of pre-registration and registration under REACH, focusing on practical aspects for companies to comply. It will also provide up-to-date information on the REACH guidance documents and tools to support companies, and discuss what is done or can be done to raise awareness of these topics.
More
The workshop aims to alert companies that they should not miss the pre-registration "window". It will explain the key elements of pre-registration and registration under REACH, focusing on practical aspects for companies to comply. It will also provide up-to-date information on the REACH guidance documents and tools to support companies, and discuss what is done or can be done to raise awareness of these topics.
More
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