Could the news that the European Commission and European Chemical Agency (ECHA) will not be meeting its self-imposed target of 136 substances by the end of 2012 be indicative of the loss of momentum in the implementation of the EU REACH regulation? On February 3, the ECHA director Geert Dancet, in an interview with Bloomberg BNA admitted that the pace of implementation of the REACH regulation was not as fast as was expected.

The commitment to have 136 SVHCs by the end of 2012 was communicated in March 2010 by JanezPotocnik, EU Environmental Commissioner, and Antonio Tajani, EU Industry and Enterprise Commissioner. The list was arrived at from a review of substances that were suggested by member states to be easier to process. A closer review of these substances noted that some of the substances are only subject to limited registration requirements under REACH (because of their intermediates status), also other substances are already regulated under different legislations (which makes double regulation unnecessary).

Dancet admitted that the screening of some of the substances proposed for authorization was done hastily and therefore was not suitable, and also remarked that member states were also falling back on their promises probably from the pressure of budget cuts.The commitment to have 136 SVHCs is nonbinding.

Dancet also observed that the ECHA has not been moving fast enough in finalizing the authorization list with only 6 substances requiring authorization out of the 36 so far proposed for authorization. This slow pace Dancet attributes partly to previous disagreements and an unstable working relationship between the environmental and the enterprise departmentsof the EC.

The new target of the European Commission is to have 15 substances added to the candidate list by the end of 2012. 13 substances are expected to be added in June, and a few others in August. This would bring the total number of substances that require registration and notifications to at least 88 by the end of the year.

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Filed under: REACH, reach authorization, SVHC Substances by assentadmin
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The European Chemicals Agency (ECHA) has published a preliminary list of phase-in substances to be registered for the first time during the 2013 REACH registration deadline. The list of 2, 300 substances was a culmination of an industry survey by the agency to get an accurate number of substances up for the second registration deadline. The survey included all the companies that had registered their intention to register for 2013 deadline during the pre-registration period.

Already, Lead Registrants for two thirds of the published substances have been selected and their names will be published by the agency. Any newly nominated Lead registrants are invited to notify the agency via the updated webforms available on its website. Lead registrants who have already notified the agency are also urged to re-submit the webform, in order to update their entries. The 2013 REACH registration deadline affects all phase-in substances produced or imported into the European union in annual quantities of 100 tonnes or more.

This list of substances will be equally useful for the downstream users to know if the substances they use are already registered or are expected to be registered by 2013. However, since the list does not include the specific uses of substances, the agency has urged the downstream users to contact their suppliers and to communicate their specific uses to make sure they will be covered in the chemical safety assessment and exposure scenarios associated with a registration.

The ECHA however added that the list is not complete as some of the contacted companies have not responded. The list will be updated on a monthly basis with the agency appealing to those registrants who have not responded to do so, to facilitate the completion of the list. The agency has consequently invited any potential registrants who intend to register by the 2013 deadline and whose substance is not yet on the list to inform it of the intention by answering the ECHA survey received by them at the end of 2011. Potential registrants are further advised to consult the list of registered substances to confirm if their substances are already registered.

 According to the REACH regulation, manufacturers are required to progressively remove substances that have been identified to be harmful. This process of removal of harmful chemical substances starts with the registration of chemical substances manufactured or imported into the EU in volumes above a set threshold.  The first registration of phase-in substances targeted substances produced or imported in volumes over 1000 tons annually was conducted in 2010. The 2013 registration deadline is the second, and targets substances over 100 tons annually. This will be followed by the final registration deadline targeting phase-in substances in excess of 1 ton annually in 2018.

More information on the preliminary list from the ECHA is available at: http://echa.europa.eu/en/web/guest/view-article/-/journal_content/ab06aa2b-8c2f-4273-a628-e2fdfaf2a6f4

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An Only Representative (OR) of non-European Union manufacturers can now file an authorization application under the REACH regulation. This decision was arrived at in December 2011 by the European Commission, which then communicated its decision to the European Chemicals Agency (ECHA). Following this decision, the ECHA has updated its web forms to allow any OR to submit an application while developing long term functionalities in REACH-IT and IUCLID 5 platforms.

Authorization is the REACH process of mitigating the risks from Substances of Very High Concern (SVHV) listed in the Annex XIV of REACH regulation. Substances subject to authorization may not be used or placed in the market in the European Union after the ‘sunset date’ unless authorization for specific uses for a specific supply chain has been granted by the ECHA. The ultimate aim is to replace the hazardous substances with safer alternatives for all non-essential uses.

Inclusion of substances in Annex XIV of REACH is the final step in the authorization process. The proposal and subsequent placement of the substances on the Candidate List are the first steps in the process. This means that as affected producers struggle to ensure continued use of their listed substances of very high concern and stay aware of the restrictions on SVHCs should they move onto the Authorization list, they equally have to comply with the immediate legal obligations and responsibilities to the producers, importers and downstream users of SVHC listing including;

• EU suppliers of articles have to inform their customers about the presence of the substance and advise on safe use in line with Article 31 of the REACH regulation
• Pursuant to Article 7 of REACH, form June 1, 2011, article producers and importers are subject to a notification obligation to ECHA in case SVHCs in their articles exceed 1 tonne in all of their articles annually, their concentration is above 0.1% w/w, exposure cannot be excluded and the substance was not registered for that use; and
• EU suppliers whose products contain SVHCs are required to provide their customers with safety data sheets.

With these requirements, for Annex XIV substances, it is advisable that affected companies initiate an expeditious search for safer alternatives or prepare for an authorization application. Currently, a total of six substances make up the REACH’s authorization list even though a total of 28 substances have been proposed for inclusion in the authorization list.

With the projected acceleration of the authorization process under the REACH in the coming months, both regulatory authorities and other stakeholders continue to offer the industry guidance on the best practices to comply with the regulation. REACH Centrum has for example organized a REACH authorization webinar on February 7, 2012. The webinar targeting company lawyers and REACH company managers will address among others: general principles of authorization, authorization time-lines, actors involved in the authorization process and the interface between authorization and restriction.

More information on the OR authorization application from the ECHA is available at: http://echa.europa.eu/web/guest

Additional information about the ReachCentrum webinar can be accessed from: http://www.reachcentrum.eu//en/learning/reach-webinars/reach-authorisation-webinar–the-principles.aspx

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Filed under: assent, Environmental Compliance, New SVHC, REACH, reach authorization list, SVHC Substances by assentadmin
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At Assent Compliance we come across droves of data about Environmental Health & Safety Management Information Systems. Since the Assent Compliance Software Suite is considered a category leader in the Environmental Compliance space we stay as up to date as possible.

Our friends at E2Manage Tech assembled a fantastic document/report we wanted to share with you. In this post we’ll list the Top 10 considerations E2 Manage Tech has outlined and then link you to their post if you want to read the full document. Great job E2MT !

Top 10 Things To Consider When Selecting an EMIS

1. Requirements Definitions: Define exactly what you need in your RFP

2. Involve IT Early: Get all major IT groups at your company involved. (Less so if a cloud based system but still applies)

3.  Avoid “Not Invented Here”:  All end users and steak holders need input as to avoid the “not invented here” effect.

4. Configurability Vs Out of The Box: Define what features are included, Vs what can’t be changed.

5. Consider the Benefit of Embedded Best Practises: Make sure the solution you choose is right for your current business processes and be aware that solutions are constantly evolving to better serve your needs.

6. Reporting: Ensure that reports are easily generated, accurate and representative of your data.

7. Evaluate the Company Not Just The Software: You will surely have regular contact with your PM and development team. Ensure that you’ll have support on an ongoing basis and not get lost in the bureaucracy once you launch.

8. Talk to Client References

9. How Will Module Phasing Be Prioritized: Is there a development road map ? What modules will you need to implement now and in the future. What are the costs ?

10. Long Term Internal Resources For System Admin: What resources will you need internally to use the system. Is it hands off, hands on, and what are the costs associated with these resources ?

Overall this is a fantastic guide that E2 Manage Tech has assembled. You can read the full document here: http://www.e2managetech.com/emistopten.pdf

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• Software Solutions for Environmental Compliance (RoHS, RoHS II, REACH, CLP, Conflict Minerals etc)
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• Conflict Mineral Compliance Services
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The Consumer Product Safety Commission (CPSC) has launched a user friendly registry for small batch manufacturers. The commission was responding to directive by the Congress to establish the registry in Public Law 112-28, which was signed into law by President Obama on August 12, 2011.

According to the notice from the commission, following the launch, manufacturers who grossed $1 million or less in revenues from sales of consumer products in 2011, and who produce less than 7,500 units of at least one consumer product in 2011 can register for the 2012 calendar year at www.SaferProducts.gov. In addition, qualifying small batch manufacturers are exempted from third party testing for compliance to certain children’s product safety rules in 2012 for products produced under 7,500 units in the previous calendar year.

The new registry however does not exempt small batch manufacturers from complying with the mandatory product standards. The manufacturers are still required to submit a certificate of conformity, to certify that their products comply with relevant regulations. The certificate must not be based on third party testing except when required by law.

Effective December 31, 2011, the stays of enforcement on third-party testing and certification for; limits on total lead content for children’s products, the ban on specific phthalates for children’s toys and child care articles, and the mandatory toy standard (ASTM F963) have ended. The commission has consequently launched an education and outreach programme to entrench the awareness of the new federal requirements to the small batch manufacturers. Directed guidance has also been extended to the manufacturers to help them understand the new requirements.

The US Consumer Product Safety Commission is the lead agency in protection of the public from unreasonable risks of injury or death associated with the use of the thousands of consumer products under the agency’s jurisdiction.

The CPSC notice on the registry is available at: http://www.cpsc.gov/cpscpub/prerel/prhtml12/12073.html

More information on the SaferProducts.gov can be accessed from: http://www.saferproducts.gov/About.aspx

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The European Commission has published its regulatory definition of nanomaterials. According to the definition adopted by the commission in October 2011, nanomaterials are those materials whose main constituents have a dimension between 1 and 100 billionth of a meter. The definition also takes into account that nanomaterials can interact with each other, forming larger structures. The formed structures (aggregates, conglomerates) also meet the nanomaterials definition.

The publication of the nanomaterials definition has been welcomed by the Europeans Chemicals Agency (ECHA), saying that the definition will clarify responsibilities for both the ECHA and other players in the chemical industry. The agency has consequently advised registrants to understand how to categorize and indicate nanomaterials in their registration data, in line with the new definition.

The rising use of nanomaterials in the EU market, and especially its relation to the REACH regulation, has hitherto been a subject of wide debate. The EC believes the new definition will harmonize nanomaterials trade in the EU market. The ECHA has stepped up its internal work-plan covering the 2012-2013 periods on nanomaterials. The agency has further appealed to the industry not to fear registering their substances as nanomaterials since there is no consistent causal link between nano size alone and hazards.

A search for the new definition was sparked by the experience in REACH’s first registration deadline of November 2010. It was noted that companies needed more clarification on their obligations on nanomaterials. The new definition which also delivers on the European Parliament commitment of 2009 on a single nanomaterials definition, is based on scientific advice from the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR)and the Joint Research Centre (JRC).

Under the REACH regulation, registrants now have an obligation to duly identify and indicate nanomaterials, providing all relevant documentation and safety information related to the substance as it is manufactured or placed in the market.

Additional information is available on the links below

http://europa.eu/rapid/pressReleasesAction.do?reference=IP/11/1202&format=HTML&aged=0&language=EN&gu

http://echa.europa.eu/en/view-article/-/journal_content/6b205e13-c94c-4a64-9810-fa90735f6d23

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The European Chemicals Agency has published its newsletter covering the second half of 2011. The newsletter that reviews emergent issues in the European chemicals industry is available on the agency’s website.

In the newsletter, the ECHA reports on the projected workload in the year 2012 with special consideration to the readiness for the May 2013 registration deadline. In this regard, the ECHA plans to assist the lead registrants prepare high- quality dossiers and chemical safety reports, and to carry out targeted communication activities to reach out to new registrants.

Secondly, with the new REACH process on substance evaluation scheduled to begin next year, the first draft Community rolling action plan (CoRAP) has been developed. The plan contains 91 substances that are proposed for review by the Member States. ECHA will also carry on with dossier evaluation, and examine testing proposals from the first registration deadline scheduled to end December 1, 2012.

On authorization, the ECHA expects an increase in the number of applications given the approaching deadline for the first substances on the Authorization List. Moreover, the Commission has set an ambitious policy target of having 136 SVHCs on the Candidate List by the end of 2012. This will force an intensive schedule on the ECHA, the EU and Member States.

In 2012, the ECHA will also prepare for an additional two new regulatory schemes: the Biocides Regulation, which is expected to enter into operation in 2013, which will transfer the operation of the EU biocides scheme from the Commission to ECHA, and a new EU authorization scheme for biocidal products. The addition of the Biocides Regulation will see the agency prepare the IT systems to receive the dossier, create the biocidal products committee as well as recruit and train experts. The recast of the PIC Regulation will transfer the implementation tasks of notifying export and import of hazardous chemicals from the Commission to ECHA.

The full ECHA report is available at: http://echa.europa.eu/en/view-article/-/journal_content/6b205e13-c94c-4a64-9810-fa90735f6d

Filed under: Annex XIV of REACH, CLP, News, REACH by assentadmin
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The European Chemicals Agency has extended the registration deadline for the Lead Registrants Workshop until Friday 13, January. The workshop whose attendance is by invitation only is scheduled for February 2-3, 2012. The agency has also updated the agenda, nature of topics to be covered and information regarding the one-to-one training sessions.

Preliminary topics for the workshop include:

• Feedback and lessons learnt from 2010
• SIEF formation and challenges
• Registration management

Registration management presentations will include case studies on data sharing, substance identification and data quality, and legal obligations of the manufacturers. On SIEF formation and challenges, the presentations will focus on case studies and available tools.

During the workshop, the ECHA will provide the participants with two modules of training on IT-tools (REACH-IT and IUCLID). The modules will be covering advanced and basic use of the tools. Registrants will be notified on how to sign up for the training this month. As a further incentive, the workshop participants will be able to attend one-on-one sessions with ECHA staff that will provide support for specific topics. Equally, the ECHA will reimburse the travel and accommodation costs of SMEs Lead Registrants facing the challenges of leading a SIEF, wishing to attend the Lead Registrant Workshop, subject to the availability of places and eligibility check

A total of 300 Lead Registrants, who have informed the ECHA of their role via the lead registrants notification web-form are expected to attend the workshop. Invitation and registration link will be sent to the Lead registrants who have met all the requirements. Selection of the participants will be done on a “first come first serve” basis. Lead registrants without prior experience in SIEF formation will be given first priority.

The workshop will also be streamed live via web to allow global participation. The link for web-streaming will be published on the ECHA website on February 1, 2012. The workshop is an effort by the regulatory body to guide the industry through the REACH compliance practice as the industry faces the second REACH registration deadline in 2013.

Filed under: News, REACH by assentadmin
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20 Substances have officially been added to the SVHC Candidate List bringing the total to 73 substances.

Please see last week’s post for information on where these substances are used.

Companies now need to assess whether they have legal obligations resulting from the inclusion of substances in the Candidate List. The legal obligations include Communication and Notification.

Any producers or importers of articles placed on the market^[1] in the EU must now declare the presence of any of these substances (in addition to the existing 53 substances) in an article in a concentration exceeding 0.1% w/w.

Furthermore, these same producers and importers have six months from today (19 June 2012)  to notify the ECHA if

(a)   the (SVHC) is present in those articles in quantities totalling over 1 tonne per producer or importer per year

(and)

(b) the (SVHC) is present in those articles above a concentration of 0,1 % weight by weight (w/w),

Finally, any chemicals placed on the Candidate List can also eventually be approved for an authorization list where they will then be banned from use unless an authorization is submitted and approved before the applicable sunset date.

Assent Compliance has a wide range of services that can help your company meet these latest REACH compliance requirements stemming from the update to the REACH SVHC Candidate list in December. These include REACH compliance software, REACH supply chain data gathering, REACH audits, Corporate REACH compliance strategy development and more.

Please contact us today for more information at info@assentcompliance.com

Filed under: Assent Compliance, Environmental Compliance, New SVHC, News, reach authorization list, REACH Software, SVHC Substances by assentadmin
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A statement from ECHA website reports that the ECHA has postponed its scheduled publishing of classification and labeling inventory under CLP regulation. The directory which was to be published on 15 December has been pushed till mid-January is to ensure that the information provided by industry will be made publicly available in an accurate way that allows easy and functional access and navigation.  This is in considering that the ECHA has received over three million notifications for only 115,000 substances.   It is apparent that companies have submitted multiple, different classification and labeling notifications on the same substances, against the procedure laid down in both REACH and CLP regulations.

According to the REACH (article29 (2)) and CLP (article 41):

Each SIEF should agree on Classification and Labeling where there is a difference in the Classification and Labeling of the substance between potential registrants”…and again…. “the notifiers and registrants shall make every effort to come to an agreed entry to be included in the inventory.

Working within a SIEF, individual registrants under the 2013 and 2018 REACH registration deadlines should have self-classified their substance(s) through a notification to the ECHA, where there is no harmonized classification and labeling as captured in Annex VI (table 3.1) of the CLP regulation. Same substance multiple notification submission is an indication that this practice has not been achieved by the industry.

Manufacturers are therefore required at this stage to confirm that their substances do not have multiple notification portfolios. Where multiple notifications have been submitted, it is important for the producers of the affected substances to expedite SIEF consultations to ensure only a single common Classification and labeling notification is submitted to the ECHA.

Upon the publication of the harmonized Classification and labeling inventory, all manufacturers of same substance will be required to observe the set requirements. The inventory will also allow the public to access information on the self-classification of chemical substances by Industry.  Assent compliance will post an update of when ECHA publishes the inventory.

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Filed under: Assent Compliance, CLP, Environmental Compliance, Environmental Compliance Consulting, REACH Software, SIEF, SVHC Substances by assentadmin
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