Web-based or On-premise Chemical Compliance Solutions?

Ready to useChemical compliance solutions come in a number of different flavors. Some alert you to new substance reports, others allow you to track substances of high concern through your supply chain. EUPHOR provides full chemical compliance project management to get you to global compliance. But when you’re trying to choose the best option for your company, there’s one question that can be decided before you start making comparisons within the software’s features: on-premise or web-based?

This questions affects chemists, project managers, decisions makers, and support staff, so it makes sense to consider the options early in your decision-making process. EUPHOR is available either as a web-based solution, or as an on-premise solution.

On-premise solutions

On-premise solutions are installed on one or more desktop computers in your offices or on a mobile device for members of your team who need to use a laptop or tablet more often than a desktop machine. However, each instance of the software is separate from the others. If your project manager wants to check on alerts, he will need to go to his computer to do so. If a chemist wants to upload a file, she will need to go to a device that has the software installed and upload the file — and the file will be on that device only, not on all the computers with that software installed.

Many facilities prefer premise-based solutions, because they allow you to stay in control of access. Your data stays in your IT system, and users must have physical access to your computers to access your data.

Web-based solutions

Web-based solutions, also called cloud-based, are different from on-premise solutions, because every authorized user can access the same information at any time. Alerts show for everyone who logs in, on any device with internet access. Files are available to all authorized users, wherever they are. Reports can be uploaded and accessed by all authorized users on any device, at any time.

That means that project management can be handled from the solution dashboard. It doesn’t require your project manager to track down all the data silos and check in with everyone. Files can be uploaded by the people in the field, whether that’s a chemist at a workstation in your lab or a remote worker testing somewhere along your supply chain with a mobile device. Time zones don’t matter, because the software is always in sync.

On the other hand, data can be accessed by anyone with log-in credentials, even if they don’t have access to your facility.

Security concerns?

Some people feel more confident with on-premise solutions because they worry about security. Security is a valid concern, but on-premise software is not always more secure than web-based software.

The most common source of security breaches is not an online attack. It’s the worker who leaves the door open and the computer on when he goes to lunch. It’s the receptionist who trustingly gives information over the phone. It could even be you, if you keep your passwords on a sticky note on the corner of your monitor. For both on-premise and web-based solutions, security issues are most often the result of human error, not of hacker masterminds.

On-premise solutions could theoretically have world-class security, if your company has world-class security. For most SMBs, world-class security is not a practical option. Frank Gillett of Forrester Research put it like this: “Using cloud services means that your data is better protected than if most of us tried to manage it on our own…Large-scale services are all much better than we are at avoiding data loss from gear failure, keeping software up to date, upgrading hardware, and constantly improving security.”

Bottom line: Security issues for on-premise and web-based solutions are about the same. The big question is whether you are prepared to take full responsibility for the security issues, or if you’d prefer to leave that worry to the software company you choose to work with.

Benefits of web-based software and on-premise software

Web-based solutions are typically faster to implement, require less up-front investment, and offer at least the same level of security as on-premise options. On-premise solutions give you complete control and may be more cost-effective over time, depending on the specific software solution you’re considering.

EUPHOR believes in giving clients the choice between cloud-based or on-premise solutions. We’ll be happy to discuss your specific needs with you and help you implement either form of EUPHOR’s compliance management solutions.

Consider EUPHOR to streamline and empower your global compliance projects management. Contact us for a live demo.

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Keeping Up with Chemical Regulations

One of the challenges in chemical regulation compliance management is simply keeping up with changing regulations. Some chemical regulation compliance management software does nothing but alert you to changes, and that can be a time saver.

But regulatory compliance for chemicals is not the same as for tax law or HIPAA compliance. It is not always just a matter of seeing the new regulations and following a simple protocol.

For REACH compliance, for example, companies are responsible for identifying substances requiring compliance, working with others manufacturing or importing the same substance, preparing joint registrations, and so on. The process is not a question of waiting for a list or update. The burden is on your organization.

Accurate identification of substances is key. There must also be a plan for testing and data allowing determination of risks to human beings or to the environment. Collaboration is required, and registration may require risk management plans if the substances in question are already identified as “of concern.”

In other words, the process is complicated. It makes sense that it should be complicated. The stakes are high, and getting things right is extremely important in the context of chemical management. That’s why it’s not enough just to be aware of regulatory changes.

EUPHOR chemical compliance management solution is different. It provides a project management component that helps you keep up on the entire process from start to finish using a single, central platform. A user-friendly dashboard lets everyone involved see the process. The clear visual presentation makes it easy to see at a glance what’s on track and the next action steps required. Automated workflow generation based on current regulations or on your own plans keeps the process as simple as possible and keeps you in the loop.

EUPHOR also makes it easy to upload, store, and share data. This feature allows you to keep all the information together and readily accessible. Other key features include automatic alerts and reminders, pre-generated queries, an so much more. To find our more, tour the product and see how Euphor can make a difference for you.

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The Precautionary Principle

Our court system is founded on the principle that the accused in any case is innocent until proven guilty; the Precautionary Principle in risk management takes the opposite approach. The idea is that a new process, product, or policy should be approached with caution — even resisted — until there is ample proof that it has no negative consequences.

History can provide us with good examples of chemicals that have been used freely until it was discovered that they posed dangers to human health or to the environment: arsenic, lead, and mercury were all used in ordinary household goods for many years. When lead was used in make up, there was no good way of testing its safety until it became clear from the consequences of its use that it was dangerous. Now, testing is routine and information about the safety of ingredients is widely available. Manufacturers are more sophisticated, regulations provide guidance, and brands take responsibility for environmental and health consequences.

Consumers are also more aware of and concerned about ingredients. They may or may not be more sophisticated than their counterparts in the days when adding “with Irium!” to packaging convinced shoppers that the product was a hi-tech miracle. Many modern consumers respond to “Natural!” in the same way, overlooking the sheer naturalness of arsenic, lead, and mercury. But modern consumers have access to enormous quantities of information — enough to spark attitudes like, “If you can’t pronounce it, don’t buy it!” and certainly enough to make the Precautionary Principle appealing.

The history of the Precautionary Principle

The term “Precautionary Principle” came into common use internationally after its introduction at the 1992 United Nations Conference on Environment and Development. It was used then as part of overall ideas on sustainable development, and has since spread in its use to many fields. It is not used identically in every context, but there is widespread agreement that it has a place in risk management, particularly in the context of human health and environmental responsibility.

Definitions of the term were offered at the conference mentioned above as well as the 1992 Convention on Biological Diversity and the 2000 Protocol on Biosafety. In these and later discussion of the principle, there is agreement that this principle can be “triggered” by an uncertain threat. There is disageement on the level of threat and the level of uncertainty that can trigger the application of the principle, but it is not necessary to prove a specific threat.

Current discussions also include debate over whether issues like cost or potential benefit can offset the perceived possible threat.

Concerns about the Precautionary Principle

Use of the Precautionary Principle ranges from the strongest version — resist any action that has not been proven safe over the long term — to weaker versions that may simply require consideration of possible consequences before taking action. Still, there are concerns about the use of the Precautionary Principle in regulations.

Cost is one of the main concerns. This is not simply a matter of corporations saving money. When regulations become excessively costly, they can stifle innovation. Time to market for new and potentially beneficial solutions can be extended beyond the level manufacturers can support.

What’s more, the Precautionary Principle can prevent comparison of new options with existing options that may in fact be more potentially harmful. A “better safe than sorry” attitude could, in theory, have kept arsenic in wallpapers and lead in make up while new replacements were thoroughly tested. The life-saving effects of vaccinations, sulfa drugs, and antibiotics could have been delayed long enough to cause thousands or millions of deaths.

The Precautionary Principle, how to define it, and how it should be triggered, is still under discussion. It is likely to continue to be highly influential in European and U.S. chemical regulation compliance management.

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Chemical Compliance Survey

Thanks for taking the time to answer our survey!

Our goal with this Chemical Compliance Survey is to gain a better understanding of your activities and the topics you would like to learn more about as we approach the beginning of 2017.

Since the holiday season is also about giving back to the community, we decided to donate $5 to the charity One Laptop Per Child for each survey completed before January 15th. 

chemical compliance survey donation to one laptop per child

One Laptop Per Child is a non-profit association whose mission is to empower children through technology. The association aims to provide children in the world’s poorest regions with a low-cost and connected laptop. With this laptop, children can learn, share, connect and create together.

 

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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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