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.
“Regulatory coherence” is a popular buzzword in chemical regulation discussions.
On the one hand, regulatory coherence — generally defined as chemical regulations that are the same or similar from one country to another — is obviously a good thing. Chemical companies and their downstream partners will find it easier, more cost-effective, and more practical to meet one set of regulations than to meet separate regulations for each of the markets they serve.
The European Commission said, “Regulatory barriers have long been recognized as the most significant impediment to trade and investment between the EU and the USA.” Regulatory coherence as a goal makes sense for all parties.
At the same time, the term is not being used the same way in every setting. And it may not be as simple as it sounds. The U.S. Chamber of Commerce specifically says that regulatory coherence ”is about good regulatory practices, transparency, and stakeholder engagement in a domestic regulatory process.” For the harmonization of different national regulatory regimes, the Chamber prefers the term “regulatory cooperation.”
The European Union’s REACH regulations are being accepted not just in the EU, but in multiple nations around the world. REACH and REACH-like regulations are being implemented across Europe and Asia. This makes it easier for these nations to trade with one another, and for other nations to reach all these markets equally.
REACH and REACH-like regulations have some things in common:
- Manufacturers and importers are responsible for preparing dossiers delineating any safety concerns for the substances they make or import.
- Manufacturers and importers are responsible for demonstrating that their substances are safe, rather than relying on government regulators to prove that the substances are not safe.
- The regulation process includes three elements: registration, evaluation and authorization. At each stage, innovation and collaboration are encouraged in an effort to reduce animal testing and to increase the use of safer substitutions.
REACH has widespread support, and countries from England to Japan are participating. REACH looks like an excellent example of regulatory coherence. But the Americas are not so far participating.
Cost-benefit and Precautionary Principles
In the U.S., chemical regulations have traditionally included an awareness of the economic consequences of regulations, while EU REACH regulations are based on the Precautionary Principle. As other nations take sides, the difference between these two basic philosophies shows clear conflicts. It may be difficult to achieve regulatory coherence if this division continues.
Cost-benefit analysis can be difficult, because so many variables are hard to quantify. If restriction of the use of a chemical results in fewer deaths, how can the value of the potential longer lives be calculated? How can health benefits be balanced against large expenses? The potential benefits of a given substance must be compared with the potential dangers, often with very little real data. This approach may also mean that expensive regulations are filtered out of discussions before enough information on the risks has been gathered.
On the other hand, the Precautionary Principle can lead to regulation with limited proof of danger. Two centuries ago, it was widely believed that tomatoes were poisonous. Regulations based on the Precautionary Principle could end up like that false belief… but it will be impossible to know ahead of time. Sir John Beddington, former chief scientific advisor to the British government, spoke strongly about the importance of distinguishing between hazard (things that could cause harm) and risk (the probability that things will cause harm).
It has been suggested that Mexico might model their chemical regulations on those of the U.S. “A modernized NAFTA has the opportunity to set a global precedent as a model for a risk- and science-based approach to chemical regulation,” the American Chemistry Council announced in a news release. “At a time when the use of hazard-based approaches is rising elsewhere, the North American region has an opportunity to play a leadership role in demonstrating the value and practicality of chemical regulatory approaches that ensure the protection of human health and the environment without imposing unnecessary costs or erecting unnecessary barriers to trade.”
Even if there is a danger of the resurgence of the New World / Old World divide, manufacturers and importers may still end up coping with a smaller set of regulations.
However, it must be admitted that it is currently hard to predict which approach to regulation will be most common. The best solution is to choose tools that will work with more than one set of regulations. EUPHOR, while it works perfectly to manage REACH 2018 compliance, can also manage any other type of chemical regulation, from internal quality standards to state or national regulations.
Schedule a demo and let us show you how EUPHOR can reduce costs for chemical regulatory compliance.
UK Prime Minister Theresa May has published the Great Repeal Bill, which will repeal the European Communities Act of 1972 and replace all relevant EU laws with identical British laws. While the bill means that the laws of the European Union will no longer directly affect the UK, it is also expected to preserve EU chemical regulations in the UK after Great Britain leaves the European Union.
The British Chemicals Industry Association expressed relief at the end of the uncertainty caused by BREXIT’s possible implications for UK chemical regulations. The Great Repeal Bill was announced last year, and at that time was understood to keep the REACH (Registration, Evaluation, Authorization and Restriction of Chemicals) Regulation as established by the European Chemicals Agency (ECHA).
However, the bill specifies that the regulations in force on the day Britain leaves the UK will be the law of the land. Changes in EU regulations, including case law, will not affect Great Britain’s laws going forward.
This factor means that, like UK English and US English, the two systems could change differently over time and end up being significantly different in the long run. Great Britain may eventually have a REACH-like chemical regulations system, as do Turkey, Korea, and a number of other nations.
This could affect companies that trade in the UK and in the EU. If meeting EU requirements allows these companies to trade in the UK as well, compliance will be simple. Additional requirements for the UK, or different kinds of dossiers, could make things more complicated.
British companies will be able to meet EU requirements as well as their local requirements at first, but changes in British chemical regulations over time could mean that they will have to meet two sets of requirements, even if Britain continues to benefit from free trade with the EU.
Some companies have already said that a choice between two sets of regulations could drive them out of the UK. Britain could try to make sure that their national chemical regulations continue to match REACH, but some experts question whether this is realistic once the UK no longer maintains involvement with ECHA.
Data sharing could also be an issue. If ECHA decides not to accept UK registrations and instead requires EU-based Only Representatives, it may be harder for UK suppliers to compete with EU vendors.
Data sharing has become an issue in some other countries using REACH-like regulations. At least Great Britain will not face language-based challenges such as those coming up in Turkey.
If UK lead registrants are importing substances into the EU, though, there may be a scramble to update or re-register substances after Britain leaves the EU. And SIEF agreements which share data only for REACH could be interpreted as applicable only to dossiers registered for EU REACH, not for a UK REACH-like law.
In some ways, the assurance that the UK will still be under REACH on the day BREXIT takes place gives certainty to chemical companies and UK importers and manufacturers of articles using relevant substances. In other ways, it just kicks the can down the road.
UK companies may need to negotiate some flexibility with co-registrants in their SIEFs. Or the UK may be able to negotiate some support in their Withdrawal Agreement. Either way, it’s likely that the REACH 2018 deadline will not be the final act for chemical companies located in or trading with the UK.
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.
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.