Regulatory Coherence

“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.”

REACH 2018

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.”

Taking sides?

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.

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BREXIT Great Repeal Bill

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.

REACH-like?

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

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.

Continued uncertainty?

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.

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Concern over EDCs in France

France’s Agency for Food, Environmental and Occupational Health and Safety (ANSES) made a decision last week to vote for the European Commission’s definition of endocrine disrupting chemicals (EDCs), after earlier concerns that the regulations being considered don’t go far enough. Specifically, the thresholds at which EDCs are considered harmful are said to be too low; newer research would, France had said, set the bar lower.

Reportedly, France agreed to vote for the definition on the understanding that it would be a starting point. A four-month period of study is planned, during which the definition can be accepted — or changed, if it appears that the definition is in fact not strong enough in its current form.

EDCs are chemicals that are known to disrupt the endocrine system in humans and other animals. The endocrine system includes all the glands of the body and the hormones they create, including the pineal gland, pituitary gland, pancreas, ovaries, testes, thyroid gland, parathyroid gland, and adrenal glands. Pesticides are one of the most common products in which these substances are used. Pesticides are often designed specifically to play havoc with insects’ endocrine systems. There is concern that products that disrupt insect endocrine systems may do the same to the endocrine systems of larger animals, including mammals and perhaps human beings in particular.

However, EDCs can be found in toys, cosmetics, plastic containers, and other household goods. BPA, for example, is a chemical identified by ECHA as a substance that may interfere with normal expression and function of hormones in the body. BPA is generally banned in France, and France has asked that BPA be placed in the “substances of very high concern” category. The BPA REACH Consortium believes that this classification would not affect current uses of BPA.

Denmark and Sweden voted against the definition, citing the same concerns that the proposed definitions are not strong enough. However, with France’s vote, the proposal passed.

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Vietnam’s New REACH-like Chemical Regulations

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.

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K-REACH Updates Make Registration Easier

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.

 

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Korea REACH Data Sharing

K-REACHKorea REACH (K-REACH) is Korea’s REACH-like chemical regulation system. Like other REACH-like systems, K-REACH works to align its goals and systems with EU REACH. Recently, Korea and the EU are beginning to work toward data sharing.

Some data sharing agreements in the EU now allow Korean registrants to use EU REACH data to register substances. Discussions between the European Commission and the South Korean authorities are working toward extending this cooperation further.

Allowing data sharing between REACH and K-REACH is expected to reduce the amount of animal testing needed and to reduce costs overall.

It’s complicated.

There are still some complications. REACH and K-REACH data requirements are not identical. There are some differences in the two systems’ definitions of good laboratory practices, for example.

Languages can also be an issue. Testing documents can be submitted in English for K-REACH, though the dossiers must be written in Korean. No European languages are currently allowed. This may be a factor in what Chemical Watch reports as inconsistent requests for reports. Sometimes “robust study summaries” are accepted, but sometimes full reports are required in order to use REACH data.

Some companies currently under EU REACH have expressed concern that their data will not be fully secure in K-REACH. There have been no incidents so far to cause these worries, but security is top of mind for many manufacturers now.

Market factors

It is perhaps not surprising that companies with a presence in both the EU market and the South Korean market are most solidly behind Korea/EU data sharing. Some companies which do not have a presence in both markets hesitate to complicate their compliance situation further.

With data sharing, updates in information from K-REACH could spark updates in the EU, and vice versa. This should, however, be a positive effect.

Reusability

Increasing the accessibility of data for all registrants has obvious benefits which may outweigh the concerns. Companies will be able to reuse data from REACH registrations in their K-REACH registrations, and vice versa.

The benefit of this ability to re-use data will be greater for companies that have good control of their data from the beginning. Re-using data that is well organized and documented is a different experience from re-using data that exists largely in email threads and physical files.

REACH compliance is a long, complex, expensive process. Using a software solution that keeps all data and communications together and fully accessible makes that data available for future use — so it doesn’t have to be done again. REACH requires companies to keep their dossiers updated, so a good software solution is necessary even if it is used only for REACH2018.

However, if data sharing between REACH and Korea REACH goes through, the ability to re-use data will make your investment in the right software go even further.

We know that EUPHOR will have significant value for you as you work toward REACH 2018 compliance, as well as for other chemical regulation regimes, whether internal, state, national, or global. Contact us to discuss your needs and learn how EUPHOR can make a difference for you.

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