ECHA head Geert Dancet spoke with the European Parliament’s Environment Committee (Envi) last week and used some strong words about chemical companies’ ongoing responsibilities under REACH. Regular dossier updates, he said, should be considered “normal.”
Article 22 of REACH
Dancet referenced Article 22 of REACH, saying that companies “ignore” this article, called “Further duties of registrants.” Article 22 lists nine reasons dossiers might need to be updated:
If there is a change in the status of the registrant, from a new address to a change from manufacturer to importer, the registrant information must be updated.
Any change in the composition of the substance has to be updated immediately.
Changes in the annual or total quantities manufactured or imported, or in the amount of a substance used in an article, by any company will require an update in the dossier. This is especially important if there is a change in the tonnage band. For example, a company that registered in the one metric tonne group meeting the 2018 deadline which increases it use to 15 tonnes a year would have to update their dossier. If the company stops manufacturing or importing a substance, they will have to update the dossier.
When new uses for a substance are discovered, that information must be updated. This is also required if a usage which was not allowed becomes acceptable.
If new evidence of a substance’s dangers to human health or to the environment is discovered, companies must update their safety data sheets and dossiers.
If the classification or labeling of a substance should change, dossier updates must reflect that change.
Any change in the chemical safety report will also trigger the requirement to update the dossier.
If the registrant believes that new testing is advisable, a testing proposal must be filed.
The dossier must also be updated to reflect any change in the availability of or access to the data referenced in the file. For example, if data was publicly available online, but the web page is taken down, an update will be required.
The new normal
Dancet said that companies should expect to update their dossiers every five to ten years, implying that some change listed in Article 22 is likely to take place in that time frame. Updating every five to ten years, he said, should be considered normal.
He also said that companies should be prepared to pay fees for those updates, because they will require work on the part of ECHA. Dancet’s remarks seem to show some frustration with chemical companies, but chemical companies also feel some frustration with REACH dossier updates. According to a recent Chemical Watch survey, chemical companies feel that they must put dossier updates on the back burner in order to meet the REACH 2018 deadline for registrations of smaller tonnage band substances.
The right tools
Meeting REACH registration deadlines is understandably top of mind for registrants. Completing required dossiers naturally brings a sense of relief. But the need for regular updates for dossiers — as well as responses to requests for more information, which can continue for years — isn’t the real problem.
For too many companies, completing a dossier is an ordeal. Data is gathered in paper documents and shared in email threads. Collaboration relies on phone calls and conversations in hallways. Information rests with different people in different places, and is only as secure and accessible as the owners choose to make it.
That’s why we created EUPHOR. It’s a project management software solution designed specifically for chemical regulation compliance. It was built in collaboration between IT experts and a chemical company, so it has the advantages of well-designed software with the insights of chemical experts. It gathers all data and all collaborations in one well-organized place, so updates are manageable no matter when they’re required. Schedule a demonstration and see just how much time, money, and stress EUPHOR can save your company.
The REACH2018 deadline for registering substances to be manufactured or imported in the EU is May 31, 2018. However, there can still be a large gap between sending in your dossier and gaining the acceptance you need to reach the European market. It can take years Arethe process to be completed.
If you preregistered, you can continue to work within the European market while you complete the registration process. The bad news is that the preregistration period took place in 2008. The good news is that some companies may be eligible for late preregistration.
Here are the questions to ask yourself if you want to preregister now.
For example, you might have been using benzene, but have only recently begun using it in quantities as large as one metric tonne. Or you might be using zinc oxide, but have only recently entered the European market.
If your substances are not on the ESR list, you will not be eligible for late preregistration.
Are you a newcomer?
Companies that didn’t foresee their current level of growth or for some other reason didn’t expect to have to register under REACH2018 may qualify for late preregistration.
Some companies may have had a wait-and-see attitude and put off taking action to comply with REACH. These companies probably won’t be able to benefit from late preregistration. Those that have just recently entered the market in the EU or are expecting to reach the one tonne level of usage in the near future are considered “newcomers” and are probably eligible for late preregistration.
Newcomers must begin the process within six months of beginning their manufacturing or importing activity with the substance.
Do you have 12 months?
The latest opportunity for preregistration is 12 months before the registration deadline. Since the final deadline for registration is May 31, 2018, the final deadline for preregistration is May 31, 2017.
After that time, companies will have to wait for approval of their dossiers to participate in the EU market.
When speed is of the essence, having the right tools is especially important. Schedule a demo of EUPHOR chemical regulation compliance project management software. It will increase your chances of meeting this essential deadline.
REACH2018, the EU chemical regulation initiative, provides a deadline of May 31, 2018, for all companies wanting access to the EU to submit dossiers for the substances they use in manufacturing. Manufacturers and importers alike must get their dossiers submitted on time — or it’s No Data, No Market!
You’ll submit dossiers for each of your substances through REACH-IT, the electronic portal for REACH.
After the dossier submission…
Are your plans for the moments after you submit your final dossier all about celebration? That’s understandable. It’s a major achievement. After just a few checks, your dossier will be accepted and you can continue to work within the EU market.
Here are the steps to acceptance of your dossier:
The business rules check makes sure that your dossier is in the right format. You’ll get a submission number if it is. If not, you’ll need to correct it and resubmit.
The technical completeness check includes manual examination to make certain that your submission contains all the required information. If you don’t pass this test, you have one chance to resubmit.
The European Chemicals Agency (ECHA) will send an invoice for the registration fee and make sure that it is paid by the deadline. If a payment deadline is missed,you’ll have to start over with your dossier submission. Late payments won’t be accepted… and they also may not be returned.
Once a decision is made, you’ll be informed through REACH-IT of ECHA’s decision. If your dossier is accepted, you can manufacture or import your goods in the EU. If your dossier is rejected, you must start over.
How long does this take?
ECHA may take a good two to three years to come back with questions. Any changes, even small omissions or errors, will require that you submit your dossier again. ECHA can choose to examine your dossier further if there are specific concerns, but they can also randomly choose your dossier for further examination even if there are no particular concerns.
Even after your dossier has been accepted, you are responsible for updating safety data sheets, updating the dossier when new information is identified, sharing information with new registrants joining your SIEF, and generally keeping your registrations up to date. You’re responsible for updating information when you receive new data from your supply chain. If you don’t keep your registration up to date, you may be required to resubmit your dossier.
Clearly, you can’t submit your dossier and forget about REACH.
Documentation is key
When a Task shows up on your REACH-IT Task page, you’ll have to respond. If you have all your information readily available, with all the details of collaboration and compliance, performing the Task will be less of a chore.
If you have to dig through file boxes, scour old email threads, and call around to figure out who has the data… REACH2018 may continue to feel like a problem for years.
A system like EUPHOR makes chemical regulatory compliance practical from start to finish. Schedule a demo and discover for yourself the difference it makes.
Where are you on the path to REACH 2018 compliance?
May 31, 2018 is the deadline for REACH. So far, 8,547 registrations have been completed, including a total of 4,257 substances. 7,937 of these registrations have been joint registrations, reducing the amount of animal testing required and making registration more affordable.
While 85% of all registrants are large companies, the rest are SMEs, including 169 micro-companies which have registered 122 separate substances.
Manufacturers and importers are about evenly represented, as long as you count EU representatives of non-EU manufacturers.
Germany is the EU country with the largest number of registrations, with over 2,000, followed by the United Kingdom with more than 1,000. The Netherlands, Italy, France, Belgium, and Spain all come in with over 600 registrants. However, there are 29 EU nations which have participated so far. Malta and Slovakia are tied with the smallest number of registrants, three, but Malta’s three registrants have registered just two substances, giving Malta the position of the smallest number of registrations.
Once REACH is completed, the result will be the largest database of substances in the world.
When we talk with companies which are still working toward REACH compliance, we hear a lot of frustration. Keeping track of all the information, all the communication among stakeholders, and all the progress in multiple areas can be overwhelming. Often, the people we speak with are trying to accomplish this enormous — and enormously important — project with email threads, spreadsheets, phone calls, and slips of paper.
If you’re in this position, you may not relate much to the triumphant victors at the top of the infographic above. You may feel more like you’re toiling on the ladders and hoping not to fall.
EUPHOR can help. EUPHOR chemical compliance software was designed in collaboration with chemical companies and has been tested and proven by many more chemical companies. It’s a completely new and practical kind of compliance management software. Let us impress you with a demonstration.
REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals), the chemical risk management system covering chemicals made in or marketed in Europe, was put in place in 2007, and the deadline for compliance is coming up fast. The object of the law is to encourage manufacturers, importers, and everyone along the supply chain to take responsibility for the use of chemicals which may be harmful to human health or the environment.
Statistically speaking, smaller companies are less likely to meet regulatory deadlines. Small manufacturing companies in the U.S. sometimes choose not to meet regulatory requirements, planning to pay fines if necessary. That’s not an option for REACH, but that doesn’t mean that smaller companies aren’t responding to REACH differently from large firms with compliance departments in place. Some U.S. companies have been questioning whether the effort involved in registering is worth staying in the European market, or whether it might make more sense just to stop supplying chemicals to the European market.
First, use the REACH Navigator to determine whether you are actually required to register or not. REACH applies only to substances manufactured or imported in quantities of one metric tonne (a bit more than a ton) or more each year. The requirements for compliance increase as the amount of the substance your company manufactures or imports into Europe. If your company deals with smaller amounts, you may not be required to register at all.
However, the cut off is about the quantity of a substance, not the size of a company. A small company that works with larger amounts of a substance will still have to meet the REACH deadline in May, 2018.
Regulations are naturally stiffer for “substances of very high concern.” These are chemicals which are carcinogenic, mutagenic, persistent, bioaccumulative, or toxic to reproduction. Companies registering these substances will have to have full information on their supply chains and on the ways that consumers might use these chemicals, including actions that are not what the company had in mind. Gathering this data can be a big job.
Smaller companies may need to spread the work out among a number of team members. There are also requirements in REACH to collaborate with other companies using the same substances. Being able to collaborate, track actions, and share data is key.
EUPHOR compliance management software can make the task much more manageable. Being able to track the entire path to compliance with one user-friendly dashboard is a completely different experience from rooting through mountains of spreadsheets and notes. Schedule a demo today and see what EUPHOR can do for you.
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.