Demystifying Regulatory Agencies

Why Titanium Dioxide is allowed in the US, but not the EU

One of the things I hear all the time on social media is about how titanium dioxide (or this additive or that additive) is in our food, cosmetic, and other consumer products in the US and not in Europe (EU). That is oftentimes true, and it’s because different regulatory agencies control different areas of the globe. In fact, there are not only US and EU regulatory agencies. Many other countries also have their own regulatory agencies.

All regulatory agencies differ in some way, shape, or form. If you’ve followed along with my other posts, you probably know that science is not as clear as we’d like. Recommendations and guidelines are only as good as the studies they originate from. Many existing studies are not reputable enough to draw solid conclusions. We think science is infallible, but science is just one big hypothesis. We think we’re right, and we have data to back up how right we are, until we discover something new. Each regulatory body interprets scientific information differently. This means agencies will come to different conclusions about what is safe and unsafe for the people they represent.

For ease of comparison, I’m mostly going to focus on US and EU regulatory bodies. Keep in mind that many countries have regulatory agencies controlling manufacturing and imports in a country or region. This means that global companies cannot only pay attention to their local regulations. They must also have a thorough understanding of regulations in other countries so they can understand if their product(s) can be imported and sold there. Typically large global companies also have large compliance teams that specialize in these areas.

An overview of the US FDA and its EU equivalent

The FDA (Food and Drug Administration) is a US government agency that regulates “human drugs and biological products, animal drugs, medical devices, tobacco products, food (including animal food), cosmetics, and electronic products that emit radiation”. In 1906, the US passed the “Pure Food and Drugs Act”. This act initiated many of the regulatory activities related to food and drugs that they are responsible for today.

There is no exact European equivalent of the FDA. However, there are two primary organizations responsible for similar items – EMA (European Medicines Agency) and EFSA (European Food Safety Authority). The EMA was established in 1995 to consolidate the various information available at a national level in the EU member states. They have regulatory authority over human and animal medicines, as well as some minimal authority over specific medical devices.

The EFSA was established in 2002 and is not an agency with regulatory authority. The purpose is “to serve as an impartial source of scientific advice to risk managers and to communicate on risks associated with the food chain”. The EFSA provides the scientific information needed for individual member states to set regulations related to food. The European Commission, European Parliament, and individual member states can request investigations by the EFSA.

Separately from these two organizations, there is also an EU MDR (Medical Device Regulation) that regulates medical devices in Europe. Cosmetics and supplements however have no EU management; the national level (individual member states) regulate these items.

An overview of the US EPA and its EU equivalent

The FDA covers many regulatory areas, but leaves out an important aspect of other manufacturing intermediates and consumer end-products that we use in our everyday lives. For this, we need to consider the US Environmental Protection Agency (EPA) who manages the Toxic Substances Control Act (TSCA). On the EU side, we can consider the European Chemicals Agency (ECHA) who manages the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation.

TSCA was established in 1976. This law requires companies to provide the EPA notification 90 days prior to manufacturing a new chemical, requires the EPA to maintain the TSCA Inventory list of all chemicals being manufactured in or imported to the United States, and requires specific reporting and record-keeping for manufacturers and importers. TSCA was amended in 2016 to make some funding and regulatory improvements. With better funding under the amendment, a new requirement for the EPA to perform risk evaluations of existing chemicals and to review all new chemicals prior to them entering the market is in place.

REACH, on the other hand, was established in 2007. As part of this process, companies must register all products manufactured or imported at volumes greater than 1 ton per year. The ECHA has authority to evaluate these registration documents and based on the data provided, potentially classify materials as “Substances of Very High Concern” (SVHC). This process typically leads to authorization and restriction of SVHC materials from manufacture or import to the EU.

Regulatory gaps and why they exist

The FDA is by far the oldest organization out of those we have covered so far at around 100 years. The other organizations and/or their involvement in regulating materials are relatively new. This doesn’t mean there was no governance at all. However, many products and materials have been in circulation longer than the regulatory agencies that govern them have been around. As an example, PFOA was first manufactured in 1947, 29 years before TSCA was established! As you can imagine, it’s very difficult to regulate an existing material without significant evidence of the harm it’s causing.

I know it’s frustrating to think about how much daily exposure to potential toxins we encounter. I know it’s frustrating to think about how the regulatory agencies that should be protecting us, seem to be failing us with the lack of regulations. For the next part of the post, I want to go into more detail about the various regulatory agencies introduced. Hopefully after this post, you can not only better understand what they regulate and how they make their decisions, but also how to get information from them and potentially influence regulations.

The United States Food and Drug Administration (US FDA) and what they regulate

There are some items under FDA authority that must be approved before they are allowed in the market. There are other items under FDA authority that are regulated but don’t have to be approved prior to market introduction. Congress makes this determination.

The FDA requires manufacturers to submit information proving the product is safe and effective for the primary product use. Then, the FDA evaluates this information and verifies it’s in compliance with applicable regulations and that the proper measures were taken to prove safety and effectiveness. The FDA approves the following types of products BEFORE their introduction to consumers:

Any human drug or biological product, like a prescription or a vaccine
High-risk medical devices
Human cells or tissues intended to be used in other humans
Direct food ingredients and ingredients used in materials that contact food during manufacturing or packaging

On the other hand, there are specific products that the FDA regulates, but they don’t require submissions ahead of time for approval. What this means is that it’s the manufacturer’s responsibility to ensure they comply with FDA rules and regulations and the FDA can perform an audit at any time to verify the manufacturer’s compliance. The products that the FDA regulates but doesn’t pre-approve are:

Any type of tobacco products
Cosmetics like lotions, nail polishes, shampoos, hair dyes, perfumes, etc.
Infant formula
Any type of dietary supplement like vitamin D, magnesium, etc.

FDA: how to interact and use their information

There are a few ways for you to interact with the FDA and the information they provide, whether you agree with their regulatory decisions or not.

A section of their website is dedicated to product recalls, withdrawals from the market, and safety alerts. You can use the search function on this page to look for a specific manufacturer or product. You can also sort by the type of product you’re interested in that is regulated by the FDA.
You can sign up for email notifications to get updates on specific topics of interest in like food additives, new regulations, product recalls, etc.
By navigating to the different products the FDA regulates in the main menu on their website, you can access many different articles and information specifically targeted for consumers. For instance, you can find a list of materials that are currently under evaluation for further regulation (titanium dioxide is on the list for food additives, believe it or not!). You can also find information and opinions by the FDA on specific ingredients and the reason(s) for their approval for use in products.

The European Medicines Agency (EMA) and the European Food Safety Authority (EFSA) and what they regulate

The EU equivalent (EMA and EFSA) are a little different. EMA does have regulatory authority over human and animal drugs or biological products, like a prescription medicine or a vaccine. Companies have to submit information to the EMA for new products falling under their regulatory authority. The EMA reviews the information and provides it to the European Commission who will make a decision on authorization of the new product. The product must be authorized prior to being marketed in the EU. EFSA on the other hand is NOT a regulatory agency. However, they were established to bring well-researched information on food products to light. This allows member states to base regulations on this information, thus leading to more consistency across the EU.

EMA/EFSA: how to interact and use their information

Here are some ways that consumers can interact with these two EU organizations.

The EMA website allows you to search for any medication they have previously authorized. They will publish summaries of each medicine for consumers to understand the primary purpose for use, potential benefits and risks of use, among other items. They will also publish in this section a summary of changes that have taken place since the original authorization. This is a great place to find information if you’re curious about a medicine you are already taking. It can also help if you want to research a new medicine to help you make an informed decision.
The EMA website also publishes a list of new medicines they are in the process of reviewing if you have particular interest in up and coming medicines for specific treatments.
The EFSA website can be most useful to search for their publications and opinions of various food additives. This will give you more information if you’re curious about a specific additive and the usage status in the EU. If you’re not in the EU, it can be a great reference point to learn more about food additives to help you make an informed decision if you want to consume them or avoid them if they are not banned in your own country.

The purpose of the Toxic Substances Control Act (TSCA)

Moving back to TSCA, which the US EPA administers, there are three major tasks they are responsible for:

New commercial chemical assessment and regulation prior to market introduction
Maintenance of the TSCA inventory list
Existing commercial chemical assessment and regulation or restriction

TSCA: New chemical requirements

For new chemicals, companies must submit a “pre-manufacturing notification” 90 days prior to the first manufacture or import of a new material. Prior to the 2016 TSCA revision, the EPA only reviewed about 20% of these pre-manufacturing notifications in the 90-day time window. This means the other 80% of materials were permitted to be manufactured or imported without full evaluation and assessment by the EPA. After the 2016 TSCA revision, the EPA must evaluate and provide a risk determination on ALL submissions. There are still some exemptions to this including companies that are manufacturing a new material for research and development purposes only, manufacturing at low volumes, manufacturing a polymer substance, etc.

TSCA: The inventory list

The TSCA inventory list is a list of allowable chemical substances for manufacture or import into the US. It currently contains more than 80,000 materials. This list consists of materials in existence prior to the establishment of TSCA in 1976. It also contains new substances that have been approved to be manufactured or imported since that time. If a material is manufactured or imported and is not on the TSCA inventory list (and doesn’t fall under one of the exemptions mentioned above), significant fines can be incurred.

TSCA: Safety evaluations for existing materials

The 2016 TSCA amendment made significant positive changes related to evaluation of existing chemicals. Previously it was under the EPAs authority to evaluate existing chemicals but there was a lack of structure and deadlines. Under the amendment, the EPA must evaluate existing chemicals using a 3-stage risk assessment. They also must have at least 20 risk evaluations on high priority substances ongoing at once. This means once a material is fully assessed and regulations determined, they must initiate the process on a new high priority material.

Stage 1. The first risk assessment stage is prioritization. This is where the EPA designates a material as high priority or low priority for initiating an assessment. They come to this designation by evaluating hazards, exposure levels, bioaccumulation potential, etc. and cannot consider costs in their evaluation.
Stage 2. If a material is a high priority, it must move to the “risk evaluation” stage. This is where the EPA collects and reviews available data. The outcome of this second stage is the determination if a substance is an unreasonable risk to human health or the environment.
Stage 3. If a material presents an unreasonable risk, it moves to the third stage which is “risk management”. Once a substance enters the third stage, the EPA must issue a proposed management rule for the substance. Stage 3 requires the rule proposal within one year and finalization of the management rule within two years. The EPA can manage risks by prohibiting or limiting the manufacture, specific use, or import of a material. The EPA can also require the addition of warnings when a material is at a specific concentration, or require additional recordkeeping or testing by the company who manufactures or imports the material.

There are opportunities for public comment in each stage of the risk assessment process. The public can also view the current ongoing risk assessment activities to better understand why a material might present a risk and when to expect more information on possible risk management activities. PFAS, 1,4-dioxane, and asbestos are all materials on the current evaluation list. One of the best ways to engage with the EPA is related to this risk management process. This process is open for public comment and many documents are published for further learning on potential materials of concern.

The purpose of Registration, Evaluation, Authorization, an Restriction of Chemicals (EU REACH)

Moving on to REACH, which is a very recent endeavor in relation to TSCA. REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) was established in 2007. The purpose is to ensure that materials already on the market in the EU (if being produced or imported in quantities greater than 1 ton per year) are safe for human health and the environment. REACH ensures that manufacturers are taking responsibility to test their material and provide the needed information to regulatory professionals in the EU in order to make a determination on safety.

How does REACH work?

The first step in the REACH process is registration. This is the act of companies assembling and uploading information on the materials they manufacture or import to the EU in quantities greater than one ton. Part of this information includes a safety and hazard analysis of the material. After receiving the registration documentation, the regulatory agency reviews the documentation and may request additional information for their review process.

If a member state has concerns over a particular material that is being manufactured or imported into the EU, they can request it to be evaluated by the ECHA (European Chemicals Agency). Each year the ECHA publishes the Candidate List of SVHCs (SVHC = substances of very high concern). The list can include any materials that a member state thinks are concerning. However, many of the SVHC list additions are due to the material being a reproductive toxin or materials that are persistent and/or bioaccumulative. Persistent and bioaccumulative mean the materials stick around for a long time in the environment or in humans. This list notifies interested parties (like manufacturers, or consumers) that materials on the list are being evaluated for authorization or restriction. This allows manufacturers to begin to look for alternatives.

When materials are added to the SVHC list, an ECHA committee also makes recommendations on a date when the material should be restricted (prohibited) from being manufactured or imported in the EU, any exemptions that may apply, and when manufacturers must apply for an authorization. An authorization means the EU will approve companies to continue manufacturing or importing a material, even if it’s on the restricted list. This can happen for various reasons including low volume, use in a specific application, etc. The European Commission finalizes the recommendation based on the information supplied by the ECHA.

California’s Prop 65, and how it can help consumers

Prior to closing out, I want to make a quick note about California’s Proposition 65. The “Safe Drinking Water and Toxic Enforcement Act of 1986” was passed in California and is now known as Prop 65. The purpose of the act is to protect California’s drinking water from contamination. Additionally, the act informs residents about possible exposure to harmful chemicals. Companies must provide a warning to California customers if exposure to specific chemicals (currently around 900 on the list) is above the threshold to cause cancer, birth defects, or male/female reproductive harm. There are also provisions to prevent significant discharge of these specific chemicals. The act does not necessarily prohibit manufacturers from using these materials, but it has encouraged manufacturers to remove these materials from their processes so they don’t have to print a warning on their material.

The Prop 65 website contains a list of chemicals to avoid based on the criteria set above. The website also contains fact sheets on specific materials for why they can be problematic and which products to avoid if you’re looking to prevent exposure to the specific material in question. While Prop 65 only applies to residents living in California, sometimes manufacturers will list the warning regardless to avoid non-compliance. This means it can also be useful to people living outside California. Additionally, anyone can access the Prop 65 list of chemicals and fact sheets to learn more about specific products and chemicals to avoid.

Are regulatory agencies behind the curve?

I hope this review of regulatory agencies helped you understand the intricacies of federal regulations. Many materials of concern were initially produced before regulations existed. Unfortunately with how our laws and regulations are currently set up, that puts the burden of proof on the regulatory agencies rather than the companies that produced them. EU REACH has taken a huge step in the right direction of pushing the burden of proof back to the manufacturers. Unfortunately that’s not how it works in the US.

I think regulatory agencies are significantly behind the curve. This is partially why I created Responsible Journey. I want everyone to have the education and confidence to make the best decisions for the health of themselves and their families.

While I certainly think regulatory agencies are behind, I understand why it’s difficult to just “ban all the bad things for us” at once. Agencies have processes and procedures to follow, and they must follow the available science. There are so many studies and so much information about various substances that exist today. It can take a very long time for scientists to thoroughly review and discuss the implications of that information. Also, it takes time to write regulations and settle on timeframes for implementation. It then takes more time for companies to enforce these regulations and ensure their products are using allowable materials without a change to product performance.

While it’s frustrating to think of all the materials that could be causing us harm in the products we purchase, we have to understand that our personal interpretations may not be as accurate and thorough as a regulator or scientist. We still may be making the best decision for ourselves, but that doesn’t always mean it’s the right decision to make as a regulator. I think it’s helpful to try to understand the background of how these regulations get set and where we may be able to influence them, and I hope you learned something new!

SOURCES:

Why Titanium Dioxide is allowed in the US, but not the EU

An overview of the US FDA and its EU equivalent