Q1 2025 Regulatory Recap: Key Changes for North America, EMEA, and AP Compliance

In the United States (US) particularly, undeniable changes are afoot and some are already being implemented. At first glance, this might seem like a US-only issue that applies to US domestic companies (e.g., companies with a Principal Place of Business (PPB) in the US). However, given the breadth of chemical regulation, the international nature of transactions throughout chemical supply chains, and the global locations owned by large manufactures, these changes need to be acknowledged and analyzed to determine what, if any, effect there will be on business practices. 

The questions for regulated industries include:  

• How will regulatory changes affect me?  

• What are the hurdles to getting a new chemical approved for use?  

• What are the timelines for chemical approval?  

These questions are not novel; however, companies must think about issues that arise through the lens in which they operate.  

Regulatory Highlights in North America 

In the US, regulated companies must be aware of a growing deregulatory agenda that values cost cutting, opportunities for innovation and growth, and executing on the desire to bring manufacturing back to the US.  

This agenda is manifesting itself in a very tangible way. Below are some recent developments: 

1. Executive Order requires all administrative staff to look at every regulation under their program to assess if it is anti-competitive and provide a list of regulations that might need tweaking programs.  
2. OMB Notice, published in the Federal Register, asks the public to go through the same exercise of identifying regulations that they see as anti-competitive. 

These two deregulatory components represent a widespread change in direction that is yet to be fully integrated.  

3. Reduction in Staff involves an effort to lean the federal government. With regard to chemical companies, there may be a concern that with fewer Environmental Protection Agency (EPA) staff, the approval processes for new chemicals may become delayed.

TSCA Updates and Implications for Companies 

When a new administration takes over, it is often no surprise that regulatory agendas change in ways that affect the regulated industry, injecting a fair amount of uncertainty for regulated industries. For example, if a chemical is newly approved right before there is a change in political administration, and manufacturing processes are already set into place, a sudden shift revoking a regulation could impact company workflows, timelines, and go-to-market strategies. 

There are two aspects of chemical risk evaluation that may change moving forward.  

1.Whole Chemical Approach   

Under the Biden Administration, there was a change in approach to assessing chemicals. Instead of assessing risks of a chemical as a whole, the Biden apporach looked at individual uses of that chemical and determined whether a risk was unreasonable based on that use (e.g., a case-by-case analysis). Regulated industry should keep in mind that this use-based approach may be reexamined again during the Trump Administration.  

2. Personal Protective Equipment (PPE)  

When writing rules that impact risk assessment, one approach is to assume that workers are not wearing PPE while completing tasks that expose them to the chemicals in question. This was the Biden Administration's assumption. Regulated industry may see calls for this to be changed, so that there is a clearer picture regarding what types of PPE are already in place and how that should factor into the equation of risk assessment.  

As a caveat, although things are changing, there are strong legal baselines that are already in place that can provide some certainty for the chemical industry. For instance, the Lautenberg Chemical Safety Act (2016) serves as a safeguard and the processes laid out reinforce the overall framework of chemical regulation.  

3. New Chemical Review Program stagnation 

Although the New Chemical Review Program mandates a 90-day review period, things have stagnated and regulated industry is seeing a 1-2 year review period.  

During the Biden Administration, there was a push to require EPA to complete administrative actions for Consent Orders and Significant New Use Rules (SNURs) before manufacturers could get started on their work. However, this would cement longer review times and the whole program may be reexamined during this administration.   

Possible outcomes include regulatory efforts to avoid stagnation, more predictable review times, and an expedited review of chemicals with significant environmental benefits.  

What do companies need to know right now? 

Companies should know: 

A) what is likely to change,

and  

B) to what extent changes will impact business decisions.

When looked at in its entirety, regulated industry will likely operate under a fairly stable framework. However, companies should pay attention to how the details change (e.g., in terms of risk assessment approvals), and they should have internal plans in place in case they need to pivot with regard to choice of chemicals. 

How can 3E help?  

There are numerous ways to handle the challenges of regulatory uncertainty. The first is to utilize horizon scanning techniques to search for both new and rescinded regulations. Keeping up with news and changes in the Federal Register takes significant time for companies. Once the updates are filtered out and only what is relevant is identified, companies still have to incorporate new requirements into workplace operations, product design workflows, and go-to-market strategies.  

3E has a portfolio of products that help industries in many sectors identify regulatory changes and mitigate risks of noncompliance.  

See 3E Insight for more information.  

Canadian PFAS Regulation Expansion 

The overall theme for Canada is an expansion of PFAS regulations beyond Perfluorooctanesulfonic acid (PFOS).  

There are two updates to be aware of are:  

• A consultation document published on risk management for PFAS  

• A State of per- and polyfluoroalkyl (PFAS) report that covers the exposure profile in Canada, risk management actions, and other related topics.  

 Companies that operate in Canada should keep in mind that things may change in that the scope of PFAS regulated may increase. Thus, those companies should track any new requirements that may impact their business.  

Key Changes in EMEA 

There are many changes to be aware of in Europe, the Middle East, and Africa (EMEA). 

In Europe, the United Nations (UN) Globally Harmonized System (GHS) Revision 11 is forthcoming.  

Notable updates include:  

• A clarification related to Aerosols and Desensitized Explosives regarding the topic of skin irritation  

• Chapter 4.2:  

• • There is a new name for the hazard class pertaining to the Ozone Layer. The class is now called “Hazardous to Atmospheric System.” 

• • There is a new hazard class for Global Warming Substances (new category) 

Below is a non-exhaustive list of other important developments:  

1. In mid-February, the European Commision (EC) announced an amendment to the EU persistent organic pollutants (POPs) regulation. The amendment affects polybrominated diphenyl ethers (PBDE) and polychlorinated biphenyls (PCBs). Companies should be aware of new Unintentional Trace Contaminant (UTC) limits and check back for updates in the second quarter (Q2) of 2025. Eight substances will be evaluated this year.  

2. The EU Community Rolling Action Plan (CoRAP) now contains 28 substances. There are 13 newly added substances, and of the 18 substances from the previous CoRAP, 3 are withdrawn. 

3. Annex 17 (XVII) of REACH is updated as of April 4th to prohibit clay targets containing polycyclic aromatic hydrocarbons (PAH).  

4. There, a new entry in Annex XVII, 50a, prohibits 18 PAH substances from being placed on the market or used in clay targets for recreational shooting practice if they contain more than a specific level of PAHs. The amendment is effective 22 April 2026.  

5. The EU Universal PFAS Ban is expected to be come into force in 2026 or 2027.

6. There is a policy regarding REACH simplification. Companies should be aware of a 10-point action plan that includes:  

• Predictability  

• Evidence based regulation 

• Avoidance of unnecessary burden  

• Improvement of data requirements and processes  

• Ensuring fair enforcement

7. An EU regulation on packaging and packaging waste aims to harmonize packaging standards across Member States. Companies should track the timelines associated with this regulation.  

What do companies need to know right now? 

Companies should know that: 

The EU is being active right now in terms of specific changes. It will be very important for companies to keep track of these changes and correlate them with the chemicals used in business practices.  

How can 3E help?  

Understanding the details of a variety of specific regulations in the EU is a challenge, but with the right approach companies can achieve compliance. It is important to keep track of which chemicals are used in each product line. The first step is to know exactly which chemicals are used in your products. The next step is to identify applicable regulatory requirements. 

Software is a helpful tool for this. 3E has a portfolio of products that help industries in many sectors. For instance, if you are looking to integrate regulatory content into an existing system, we can help.  

See 3E ERC and 3E ERC+ for more information. 

EMEA and APEC Regulatory Updates 

Below are select updates that companies should be aware of with a focus on the UK and China. 

EMEA Regulatory Updates 

Companies who operate in countries who are parties to the Agreement concerning the International Carriage of Dangerous Goods by Road (ADR) must publish their national directives by the end of June 2025.   

Companies in the UK should be aware of three changes:  

1. Changes to REACH Fees 
2. The Classification, labeling and packaging of chemicals (CLP) List Revision (in particular, note changes to the GB mandatory classification and labeling list (GB MCL List). 
3. Two amendments related to POPs 

APAC Regulatory Updates 

China is one of the biggest chemical manufacturers and users. Companies should be aware of significant updates to the regulation of hazardous chemicals – in particular, the use of traceable codes.   

China’s New Hazardous Chemicals Compliance Requirements 

Shanghai is the port that is most active in China and there is a significant amount of chemicals imported and thus Shanghai took the first step in tracing hazardous chemicals by using a QR code.  

Changes regarding hazardous chemicals are applicable to chemical manufacturers and/or distributors exporting hazardous chemicals to China through the Shanghai portal. If a company circulates, stores, sells, and uses hazardous chemicals in Shanghai, then you need Shanghai's traceable QR code on packages. Note that Shanghai's traceable QR code contains more information than the National NRCC code. 

The use of the traceable QR code is mandatory, and there are specific rules regarding the process of attaching a QR code to a package and the scanning of QR codes. It is essential that foreign companies review these requirements.  

Regarding China as a whole, companies should prepare their SDS based on GHS Rev. 8.  

What do companies need to know right now? 

Companies operating in EMEA and APEC need to be aware of specific changes in the UK and China.  

Companies should know:  

• How to comply with the three updates noted above pertaining to the UK  
• Whether they need to use Shanghai's traceable QR code.   

How 3E Helps You Stay Ahead 

3E can help address difficulties in tracking specific regulations in different countries. For example, 3E Generate and 3E Authoring Services can help companies that need to prepare SDS according to updated standards (e.g., Chinese companies must create SDS consistent with GHS Rev. 8).  

Companies seeking to manage compliance throughout their supply chains can use software such as 3E Exchange.  

Companies in any industry or location can utilize 3E software such as 3E Insight to accelerate market readiness.  

To stay current with all of the latest regulatory updates, join us at our next Regulatory Roundup webinar. Find details in the 3E webinar resource center.