The final deadline for REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) is coming up in less than a year. Many SMEs are still working toward registration of substances. Once this process is well underway, however, there are still updates to complete. Safety Data Sheets for mixtures are among the most common challenges.
Formulators have specific responsibilities as downstream users under REACH, just as manufacturers and importers have responsibilities.
One particular challenge in this case is the choice between LCID (Lead Component Identification) or SUMI (Safe Use of Mixtures Information) methodologies.
Lead Component Identification
Sometimes called a “top down” approach, Lead Component Identification starts with the data for substances contributing to exposure in end-use scenarios.
Manufacturers provide information about their substances, including Chemical Safety Assessments and also Safety Data Sheets and information for end-use scenarios relating to their substances.
In some cases, this information may cover exposure concerns. If formulators use information about the most significant or hazardous substances in their mixtures, that information may cover the requirements for their safety data sheets.
If you can’t confirm that the end use scenarios provided by chemical manufacturers are the same as the use scenarios for your mixtures, you can ask the chemical manufacturers to add your end-use scenarios, change to a supplier whose SDS and use scenarios match yours, or create your own.
REACH has templates you can use. CFIC provides a guide for LCID.
Safe Use of Mixtures Information
Te SUMI or “bottom up” approach starts with safe use guidelines relevant to your end-use scenarios. If safe use guidelines for your substances already exist — and they match your end-use scenarios — you can incorporate that information into your safety data sheets.
If SUMI reports already exist for all the substances in your formulation, you can append the SUMI reports to your SDS.This requires that the SUMI reports include environmental, worker and consumer exposure. It is also essential that the exposure scenarios match those for your formulation.
If the SUMIs aren’t properly aligned with your needs, you can reference them and include their data in your Safety Data Sheets.
So — LCID or Sumi?
To some extent, the choice between LCID and SUMI approaches may come down to which is readily available for the substances in your mixtures. However, it may be necessary to combine the two approaches.
One of the big questions: will SDS software providers include LCID or SUMI tools in their solution packages? “Many SMEs need to keep track of imported and manufactured quantities,” an expert in the field assured us, “and need good software solutions.” You also need software solutions that help guide you through the process and keep all your data accessible. Schedule a demo of EUPHOR and see what a difference we can make.
Who among us has never felt frustration with a deadline? Chemical Watch reports that companies working toward the REACH 2018 deadline are experiencing plenty of frustration, according to trade organizations.
Companies that have already submitted dossiers find that it’s hard to keep up with the necessary updates for those dossiers when they are, first, still receiving requests for more information, and second, trying to get REACH 2018 substances registered.
Requests for more information
ECHA started off with reminders to companies which had failed to provide complete dossiers because the required tests were not yet completed when they registered. The companies were given a new deadline and ECHA provided support for completion of the dossiers. They’re pleased to report that only one registrations was revoked, out of 140 requests. They tried a second campaign focusing on invalid data waivers and once again had to revoke only one registration.
ECHA sees these campaigns as successful, and is continuing to reach out to groups of companies with these requests. They have similar campaigns planned into the future.
But companies receiving these requests are having trouble managing both the updates on their already-submitted dossiers and preparation for the REACH 2018 deadline.
It isn’t only incomplete or contested dossiers that have to be kept up to date. All dossiers must be updated whenever new information becomes available. With the REACH2018 deadline approaching, companies concentrating on the 2018 deadline are perhaps naturally not thinking about their completed registrations.
At the same time, many smaller companies are still not aware that they need to register substances, according to trade organizations. As these companies enter and join existing SEIFs, dossiers will have to be updated, cost sharing will have to be adjusted, and labs may be stretched thin responding to testing needs.
The demands of REACH 2018 are expected to become more challenging as the deadline comes closer… increasing the challenges of keeping current registration dossiers up to date.
ECHA recommends that companies which have already registered make the effort to stay up to date. Their specific advice: “proactively get your registration in order.”
Automating parts of the process and keeping data in order can reduce the time required to keep dossiers current. Are you still relying on paper, files distributed among multiples computers, and email to track your progress? That approach is slow. What’s more, keeping information up to date requires multiple contacts and lots of searching.
Switch to chemical regulation project management software and see the change in efficiency, speed, and stress reduction. Try EUPHOR — it’s designed to manage all chemical compliance software, up to the next deadline and beyond.
The LCSA updates to the TSCA have been bringing up lots of conversations, but it’s not completely clear how they’ll affect manufacturers and importers.
A recent survey within the chemical industry identified the challenges chemical companies are preparing for as the EPA works out the details of the changes to the Toxic Substances Control Act of 1976 that will take place under the Frank R. Lautenberg Chemical Safety for the 21st Century Act.
Generating relevant scientific data
The big change for U.S. chemical companies is that substances have previously been innocent until proven guilty. It has been up to the government to identify risks and prove that they are unreasonable risks, considering both safety and economic factors. Now, while the EPA is still responsible for identifying risks, it will be easier for the agency to ask for data from chemical companies and manufacturers.
Businesses are concerned about the amount of testing they might have to undertake, and the amount of data they may have to provide. The EPA can’t just agree that they don’t see any unreasonable risk in the data the company provided. They have to make a definite determination that a substance is or is not reasonably safe. They can ask for more information if they don’t initially get enough data to make that decision.
Chemical companies are concerned that the new requirements will require additional laboratory services, additional chemical literature searches, and other extra work that will require additional time and increase costs. Chemical companies can ask the EPA to do all the risk assessment for them, but they will be expected to pay the full cost.
Managing confidential business information
Companies are also concerned about data-sharing. While the experience with REACH has shown that these kinds of worries can be overcome, the United States is just beginning to face security worries relating to chemical regulations.
There is also concern about companies’ reputations as more substances are identified as hazardous. Handling the public perception of information can be an important strategic issue.
It is expected that approval of requests not to divulge information because it’s confidential business information (CBI requests) will be less common going forward.
The TSCA Inventory Reset
The EPA believes that information on the amounts and locations of chemical substances may not be accurate. They re asking for an “Inventory Reset” — up to date information on stockpiles of substances.
Processors as well as manufacturers and importers may be affected by the reset. Companies all along the supply chain may need to notify the EPA of substances they keep in inventory. Cooperation and collaboration along supply chains will be essential for accuracy, since substances are likely to be moving along the supply chain as the notifications are made.
EUPHOR chemical regulation compliance project management software is suited to all chemical regulations, whether global or internal. Schedule a demo and let us impress you.
Turkey’s REACH-like chemical regulations, known as KKDIK, have been published and will go into force before the end of the year.
According to ChemSafetyPro, the regulations will take effect on December 23, 2017. The new regulations have been known as “Turkey REACH.: The official name, KKDIK, is an acronym for “Registration, Evaluation, Authorization and Restriction of Chemicals” in Turkish.
Under KKDIK, substances manufactured in Turkey or imported into Turkey in quantities of at least one metric tonne per year will have to be registered. December 31 of 2023 is the deadline for registration of substances already on the market at that time. December 31 of 2020 will be the deadline for preregistration.
REACH had a series of deadlines based on the volume of substances used. This brought the largest companies with the highest volumes of substances imported or manufactured in first, followed by smaller companies, with the largest number of companies, many of them SMEs, working to meet the REACH 2018 deadline. KKDIK has the same deadline for all quantities of substances. Larger and smaller companies will need to meet the same deadlines.
KKDIK will replace the following chemical regulations regimes in Turkey:
- Inventory and Control of Chemicals
- Preparation and Distribution of Safety Datasheets for Hazardous Materials and Products
- Restrictions Relating to the Production, Supply to the Market and Use of Certain Hazardous Materials, Products and Goods
As under REACH, preregistered substances will be able to continue to enter the Turkish market while they work on their dossiers.
REACH and KKDIK data-sharing
The Turkish Ministry of Environment and Urbanization published the new regulations on June, 23, 2017. REACH Global Services describes KKDIK as “almost a copy-paste” of the EU REACH regulations.
There is some concern, however, that a shortage of qualified translators and Certified Risk Assessors could slow down the compliance process for companies outside of Turkey. All documentation must be submitted in Turkish, and Chemical Safety Reports must be signed by a Turkish local Certified Risk Assessor. Safety Data Sheets also must be signed by Turkish experts.
Because of the similarity between REACH and KKDIK, many companies hope to be able to use the same data for KKDIK. However, all data files will have to be translated into Turkish for submission and many documents will require local certification.
There may still be plenty of discussion about how data-sharing can be accomplished. Having all of your REACH data in order and easily accessible will doubtless improve the compliance process for Turkey’s new regulations.
EUPHOR can make the difference. Schedule a demo today and see how.
Vietnam is about to roll out new chemical regulations. The new chemical regulations have a lot in common with REACH, the European Union’s chemical regulations.
Like REACH, Vietnam’s regulations require manufacturers and importers to declare the chemicals they’re using, and to register any new chemicals they intend to use. Like REACH,the new law requires identification of the substances, safety data sheets, and substance dossiers.
Unlike REACH, Vietnam requires safety data sheets in Vietnamese and the manufacturer’s original language. The law exempts chemicals used in quantities smaller than 100 kg per year, not the one metric tonne which is the cutoff for REACH.
This is an update of the 2007 law, which focused on labeling and safety data sheets for substances of concern. The new regulations, which have been sent to the government for signatures, are expected to include more detail about inspections than the 2007 law. A Vietnamese government website reported in April that small business compliance with chemical regulations was poor.
Access to Vietnamese markets
Vietnam was identified in a recent issue of Harvard Business Review as a “frontier economy” — one which may be risky, but which also promises the kind of fast growth emerging markets in countries like India and China no longer show. U.S. exports to Vietnam have increased by more than 77% — more than $4.4 billion — over the past two years.
With 93 million consumers and a high level of political stability, Vietnam will be an increasingly attractive market for global companies in the near future.
Compliance with chemical regulations will be essential for companies hoping to break into the Vietnamese market.
This is one of the many reasons that we believe that EUPHOR is the right chemical regulations management software for most companies. When you use EUPHOR to streamline your REACH 2018 compliance, you are making an investment. It’s not just the cost of the software, but also your investment in getting your team on board, training, and configuring the software to work perfectly with your workflow.
If you need to embark on more compliance projects, you don’t need to find and implement a new software package. EUPHOR is designed to work with any chemical regulations compliance project.
K-REACH, South Korea’s REACH-like chemical regulation system, has backed off in order to make registration of chemicals easier for the South Korean market.The K-REACH updates are focused on reducing data requirements and making it easier for co-registrants to work together.
Secondary data is acceptable.
Registrants can use publicly available data from a “credible” organization instead of doing their own testing. This means that information from the ECHA website, journal articles, and public reports of testing can be provided instead of a complete dossier including test data.
One of the goals of REACH is to promote data-sharing that will allow safety of substances to be established with less animal testing. Instead of requiring each company to perform safety tests, REACH 2018 encourages multiple companies to co-register when they’re working with the same substances. A company which has already performed tests can share the information — and the cost of the information — with other companies. This reduces redundant testing, reduces the total amount of animal testing required, and helps with the cost of necessary tests.
K-REACH is taking this a step further by allowing dossiers to include the results of testing by other companies or organizations, under three conditions.
- First, the information must be publicly available. The contact information for researchers or test result owners must be available, so that the data can be reviewed and questioned if necessary.
- Second, the data must come from a credible organization.
- Third, the company using the secondary data must have the right to use the information. If testing data is available online, for example, the company using that data must have permission to use the data. Consent for use of data from journal articles must be obtained from the author or publisher who owns the rights to the data.
As long as these conditions are met, the registrants do not have to provide full test results.
A larger role for The National Institute of Environment
The National Institute of Environment’s Minister of the Environment will have a larger role in the K-REACH approval process. For example, the Minister will prioritize substances being registered, so that substances of higher concern can be handled sooner than substances that are not a source of concern.
The Minister of the Environment will also arbitrate disagreements among co-registrants.
This greater government involvement may be more practical for South Korea than for the European Union, where multiple member states could complicate increased government involvement. However, Korea has also found it more difficult to sort out co-registration issues, according to Chemical Watch, because collaboration among the companies involved is a newer concept in Korea than in the EU.
According to ChemLinkedPro, only 315 of a necessary 510 priority existing chemicals (PECs) have been registered so far under K-REACH. There has also been some opposition from business leaders in South Korea.
Whatever the motivation, the changes in K-REACH should make it easier for companies intending to trade in South Korea to complete their registrations by the deadline.