Meet EUPHOR at GlobalChem Conference 2017

Global Chemical Conference in Washington DC by SOCMAEUPHOR, Global Compliance Management Software, is proud to sponsor the upcoming GlobalChem Conference. Our team will be presenting and exhibiting at Booth #11 from February 22 to February 24 in Washington, DC. 

Join EUPHOR’s VP of Operations and Product Development, Ankur Saxena, on the first day of conferences Feb. 22 at 1:30 p.m. as he will be conducting a presentation on How to Successfully Address the Impacts of global REACH-like Regulations? Audience will gain a perspective regarding how digital solutions can help with the management and monitoring of global compliance activities.

To set-up a meeting or demo during the show, contact sujayk@euphoreach.com.
For the full list of our events, visit http://www.euphoreach.com/euphor-events.

 

About GlobalChem: 

For over 30 years, GlobalChem has been the chemical industry’s premier policy and regulatory conference of its kind. Each year, this annual gathering of industry professionals offers a valuable opportunity to review key developments in the global chemicals management arena while looking ahead to some of the most pressing issues the industry faces. GlobalChem 2017 will include discussions about LCSA Implementation, Risk-Based Chemical Regulation, Sustainability, Chemical Management in the Value Chain, REACH 2018, Canadian Chemical Management Plan (CMP) and much more. 

 

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REACH Webinar: Q&A Session

We received a lot of questions following our recent REACH Webinar. Our presenter, Carlos Miguel Fazendeiro, took the time to answer each of them. We have gathered all the answers below. If you have additional questions, please email us at info@euphoreach.com.

Want to watch the webinar? Click here for the on-demand version: http://www.workcast.com/?pak=7182697357777640.

Who can be appointed as an Only Representative? Can I ask my consultants in Europe to act as my OR?

Firstly, only a non-European Manufacturer may appoint an Only Representative in the EU, a distributor or sales agent cannot.

If you are a manufacturer, you can ask the consultancy firm you work with to act as an OR as long as the company complies with Article 8:

Article 8_Only Representative

An OR should also comply with the best practices recommended by the Only Representatives Organisation (ORO).

ORO best practices 1

oro best practice 2

If my manufacturer registers a substance I use, does this registration cover me?

We need to consider two situations:

  1. Manufacturer located outside the European Union: The manufacturer may decide to register by appointing an OR, necessary to guarantee that the quantities to be imported into the EU are covered by the registration tonnage band. However, the manufacturer can also decide not to register or the total quantities imported may not be covered by the registration. The client will then become an importer with registration obligations. 
  2. Manufacturer located in the European Union: It is mandatory for the manufacturer to register in the applicable tonnage band in order to produce and place substances on the market. The client will become a downstream user with no registration obligation.

Remark: To be able to fully answer this question, it is also necessary to verify whether the registration will be done as intermediate or full substance and whether the uses will be covered in the dossier.

When a company is engaged in a joint registration, will additional requests from ECHA beyond the 2018 deadline be fulfilled jointly or by each company individually?

This depends on the type of additional information requested.

If the additional requests concern the section 2, or sections 4 to 7 of the lead dossier (additional data required, example read-across or waiving not accepted) or the joint CSR, then additional costs need to be shared equally and the updates must be submitted by the Lead Registrants.

If the requests relate to a company’s own CS d R, uses, substance composition (missing spectral/analytical data or low quality of data) or even not in compliance with the boundary composition defined by the lead registrant, then additional requests and their associated costs are the responsibility of each company.

Once approved by ECHA, are registrations time-limited?

No, registrations are not time-limited. The requirement however is that, unlike authorizations which are provided for a certain period and require renewal, registrations must be kept up-to-date. Updates may regard tonnage that may be exceeded, administrative data, new uses, new data on substance properties and classification.

During the Stakeholder’s Day in Helsinki last May, ECHA mentioned that a dossier is considered unreliable if it is not updated after 5/6 years.

In case of intermediate for which no data has ever been generated, which studies should be launched for CLP aims? Is it mandatory?

This has to be evaluated by a toxicologist depending on the substance. It’s not mandatory but recommended if there is no information available that could confirm or allow to establish a classification and labelling. In case of transported isolated intermediates in quantities above 1000 ton/year, Annex VII studies are mandatory.

If a company has a material which was not developed or introduced during the REACH Pre-registration era, what happens to this materials? Do the same deadlines apply?

In the case of a non-phase in substance, it is necessary to submit an inquiry dossier to ECHA as only phase-in substances can benefit from pre-registration. However, after the 31 May 2018 deadline, both phase in and non-phase in substances will require an inquiry and registration to be submitted prior any manufacturing or importing above 1 ton.

Are there specific requirements for businesses located outside of the EU that are supplying chemicals on the REACH list to companies within the EU?

A non-EU manufacturer has 2 choices:

  1. Appoint an Only Representative (OR) in the European Union to take over the registration of the substances. In this case, the EU clients/importers will not have to register as they will be covered under the umbrella of the OR.
  2. Export to the European Union having the importers registering by themselves the substances as such or in mixtures. It is important to know that most importers do not like this approach and prefer to buy from non-EU suppliers that have appointed an OR.
Can REACH data be used outside the EU?

REACH data can be used globally by the data holder but only if the quality is sufficient (testing done under GLP) and in accordance with the requirements of other non-EU countries.

Companies that do not own the data but have only purchased a Letter of Access need to check if it includes the use in other jurisdictions. In most cases this does not happen and additional payments may be necessary.

How does a EU buyer handle the importation of a petroleum product that arrives at discharge port meeting the required physical specification but has a CAS number that he has not registered? Can he physically discharge? Can he reclassify the product using the CONCAWE shortlist?

If the importer has a registration for a specific CAS and is importing a substance with a different CAS number, this would not be covered by the registration.

However, if you can prove through testing that the substances are the same, then it would be necessary to agree with the non-EU supplier to change the CAS number accordingly. Otherwise, problems with customs and authorities would arise.

Download the webinar’s slides below:
[email-download download_id=”2208″ contact_form_id=”2207″]
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REACH 2018 Webinar Summary: Updates, tips and business case

reach 2018 webinar on demand banner echa chemicals

EUPHOR, in partnership with ECHA and Elementis Specialties, held a live REACH 2018 Webinar on July 13th. If you’ve missed the live event, don’t worry, here is a link to the on-demand version and a short summary of each presentation. Email us at info@euphoreach.com if you have any questions!

On Demand Webinar Schedule a Demo

The REACH 2018 deadline is the perfect example of how today’s regulatory environment is becoming increasingly complex and labor-intensive. Finding the time and resources to meet the requirements and monitor the progress of each registrations can be pretty overwhelming.

How does one track hundreds of tasks? How can a team collaborate efficiently across an organization and its external service providers? There’s got to be a better way to manage your compliance programs, right?

You need answers, and we’ve got them!


REACH 2018: ECHA’s Updates & Support

By Laura Walin, Directorate REACH Registrations, ECHA

Mrs. Walin started off by stated to challenges inherent to the last phase of REACH. The 2018 deadline is affecting a much bigger proportion of SMEs than the previous phases. These SMEs will often have little to no experience when dealing with global regulations and will for the most part take one registrations as lead registrants. Another challenge of REACH 2018 lies in the numbers of substances affected. ECHA expects to receive many more registration dossiers than what was submitted for 2010 and 2013 combined. Finally, because REACH 2018 affects small quantities of substances, information is less available and companies will have to generate new data.

Next, Mrs. Walin focused on how ECHA is helping companies go through the registration’s steps. Most tools (support, help desk, latest news and webinars) are available on ECHA’s website at http://echa.europa.eu/reach-2018. ECHA’s support strategy is based on its REACH Roadmap (see below) for which the agency has developed specific supporting and guidance materials. ECHA also recently released the latest version of REACH IT tools, IUCLID 6 and REACH-IT, making sure they were more user friendly and easy to set-up.

reach 2018 roadmap echa

To conclude, Mrs. Walin shared key messages to remember. First, organizations are not alone in this process. Although challenging, REACH registrations are manageable and companies can seek the help of ECHA, national authorities and industry organizations. She suggests to start as early as possible in order to meet the May 2018 deadline. Finally, it is recommended to implement an on-going REACH program that will permit to easily keep registrations up-to-date, especially passed the 2018 deadline.


BUSINESS CASE: How Elementis has been able to manage and monitor their registrations in a more efficient and confident manner?

By Stelios Kouvroukoglou, Product Stewardship Manager, Elementis Specialties

Elementis Specialties offers high technology additives and technical service for high performance markets. The organization is focused on developing and marketing novelty chemistry around the world. This signifies that Elementis has to comply with REACH regulations as well as the regulations of many other countries. It also means that most of the registrations has to be done as Lead Registrant.

As the Product Stewardship Manager of Elementis, Mr. Kouvroukoglou is directly involved with REACH registrations on a daily basis. He explained that REACH 2018 has been really challenging for his team has the number of registrations has gone from only 23 registrations in 2013 up to 131 for 2018! Each registration requires 100s of tasks and the collaboration of various persons internal and external to Elementis. This, in addition to limited resources, makes it hard to manage and track registrations and make sure nothing gets missed.

This is why Elementis decided to partner with our firm and implement EUPHOR. EUPHOR has allowed them to make their registration processes streamlined and worry-free. Using a single, user-friendly platform, Mr. Kouvroukoglou is able to track the status of each registration, monitor everyone’s tasks, share and receive important documents, and plan activities coming ahead.

solution to reach - organized team work - management registration

Mr. Kouvroukoglou adds that EUPHOR has allowed his team to let go of the complex Excel spread sheets and free up resources to handle actual data collection tasks necessary to build strong dossiers. Finally, when sharing his person sentiment about EUPHOR, Mr. Kouvroukoglou said it is a very easy to use system that has given him the peace of mind that dossiers will be ready on-time and on-budget. He also likes to have access to all relevant document in one single place and be able to collaborate with his registration team seamlessly.


EUPHOR’s Vision: Take advantage of REACH 2018 to implement robust IT Compliance platforms

By Sujay Keshavamurthy, Director of Product Development, EUPHOR

IT is increasingly called upon to provide organizations a set of tools to gain a greater situational awareness and control over Global Compliance. Surveys have shown that the demand for IT solutions for chemical control management will continue to increase in the coming year.

The main factors behind this increasing demand are the countless controls imposed on the chemical industry. Most countries have now implemented legal frameworks affecting chemical-based products (EU-REACH, K-REACH, China REACH, etc.). This creates an unstable business environment where product stewardship professionals must track numerous laws while managing all the activities involved within each program.

At EUPHOR, we strongly believe that Compliance departments should benefit from appropriate IT solutions, just like Finance, Sales, Marketing and R&D do. Regulatory projects should not be managed manually, there is too much at stakes. Remember ECHA’s mantra, “No Data, No Market”.

This is why EUPHOR was created, to streamline compliance processes across organizations. EUPHOR helps users save time and money, track the status of their registration instantly, meet the deadlines, improve collaboration among internal and external stakeholders and safely share and store data to facilitate future audits and other regulatory programs.

REACH 2018 global compliance road relax

Sujay concluded the webinar by stressing the fact that REACH is not a one-time operation. It impacts the way organizations do business and approach regulatory requirements in the long run. At EUPHOR, we suggest that organization take advantage of REACH 2018 to lay the foundation for on-going compliance processes that will help in the long run.

To view the full REACH 2018 webinar or schedule a demo, click the buttons below.

On Demand Webinar

Schedule A Demo

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