Freyr GRI

If you've worked in regulatory affairs long enough, you know one thing for certain:

The regulations never stop changing.

But 2026 feels different.

This isn't just another year filled with updated guidance documents or revised compliance checklists. Across pharmaceuticals, medical devices, and cosmetics, regulators are fundamentally changing how they expect companies to develop, evaluate, and monitor products.

Digital submissions are replacing traditional workflows. Cybersecurity has become a regulatory expectation instead of an IT concern. Product safety monitoring is becoming more transparent. Even the scientific methods used to evaluate medicines are evolving.

For companies operating globally, these aren't isolated updates—they're signals that the future of compliance has already arrived.

Compliance Is Becoming Smarter, Not Just Stricter

For years, regulatory teams focused on staying compliant with existing requirements.

Today, the challenge is different.

The question isn't "What are today's regulations?"

It's "What will regulators expect next?"

Health authorities are increasingly encouraging innovation while simultaneously demanding stronger evidence, better documentation, and greater visibility throughout a product's lifecycle.

That means organizations need to think beyond regulatory submissions. They need continuous awareness of what's changing around the world.

Pharmaceuticals Are Entering a More Digital Future

Drug development has always required scientific rigor.

Now it also requires digital readiness.

Regulatory agencies are encouraging structured submissions, modern statistical approaches, and greater use of existing scientific evidence to improve review efficiency.

For regulatory professionals, this represents an opportunity to spend less time navigating administrative complexity and more time focusing on scientific strategy.

Companies that embrace digital regulatory processes today will likely find themselves better prepared for tomorrow's submission expectations.

Cosmetics Are No Longer "Lightly Regulated"

Many people still assume cosmetics have relatively simple regulatory requirements.

That assumption no longer reflects reality.

Authorities continue to strengthen oversight around manufacturing facilities, ingredient transparency, safety documentation, adverse event reporting, and product registrations.

Consumers also expect greater transparency than ever before.

Regulatory compliance has become a key part of building consumer trust—not just satisfying regulators.

Medical Device Innovation Comes With New Responsibilities

Healthcare technology continues to become smarter and more connected.

Medical devices communicate with hospitals, smartphones, cloud platforms, and healthcare providers every day.

With that connectivity comes responsibility.

Cybersecurity is now an essential part of regulatory compliance.

Manufacturers must demonstrate how devices are designed, tested, monitored, and maintained to reduce cybersecurity risks throughout their lifecycle.

Security is no longer something that's added at the end of development.

It's expected from the very beginning.

The Biggest Challenge Isn't Finding Regulations

Anyone can search regulatory websites.

The difficult part is understanding what those changes actually mean.

Will they affect future submissions?

Will existing products require updates?

Could timelines change?

Should documentation be revised?

These questions require more than regulatory monitoring.

They require regulatory intelligence.

Organizations that can transform regulatory information into business decisions are the ones best positioned to launch products faster while reducing compliance risks.

Looking Ahead

The pace of regulatory change isn't slowing down.

Artificial intelligence, digital health technologies, personalized medicine, cybersecurity, and global harmonization will continue reshaping compliance for years to come.

For regulatory professionals, staying informed has become just as important as staying compliant.

The companies that succeed won't simply react to regulatory changes—they'll anticipate them.

Interested in learning more about the major pharmaceutical, cosmetics, and medical device regulations shaping 2026?

Freyr RegIntel has published an in-depth guide covering the latest regulatory developments, practical business implications, and what organizations should prepare for next.

👉 Read the full article here:

2026 is bringing major regulatory changes across pharmaceuticals, medical devices, and cosmetics.

From evolving EU pharmaceutical legislation and FDA guidance to MoCRA enforcement and medical device cybersecurity, staying ahead is more important than ever.

Explore the key regulatory updates shaping 2026 and what they mean for your compliance strategy.

A moment of silence for every browser that didn't survive manual regulatory research

If your team is juggling authority websites, PDFs, translations, and countless browser tabs just to find one update, you're not alone.

freya.intelligence brings regulatory updates, context, and source information together in one place, so you can spend less time searching and more time making confident decisions.

Why Chemical Regulatory Inspections Are Getting Tougher — And How to Stay Ready

Regulators around the world are no longer satisfied with a quick glance at your paperwork. Today's inspections dig into hazard classifications, Safety Data Sheets (SDSs), labels, and even your marketing language — checking that everything lines up and holds scientific water.

Whether the framework is OSHA's Hazard Communication Standard (HCS), the EU's CLP Regulation, REACH, or another chemical safety regime, every inspection is really asking the same question: can you prove your hazard communication is accurate, complete, and consistent — end to end?

What Inspectors Actually Look At

At the core, regulators want to know whether your hazard communication program is scientifically defensible and internally consistent across every document that touches it.

1. Is the Hazard Classification Actually Right?

This is usually the first thing inspectors dig into. They want to see:

The classification methodology you used

The scientific evidence behind each classification

Whether you applied a sound Weight of Evidence (WoE) approach

Alignment with the latest regulatory criteria

Consistency between your SDS, your labels, and any notifications you've filed

Newer hazard classes add another layer of complexity, so make sure your classifications account for:

Endocrine Disruptors (ED)

PBT / vPvB substances

PMT / vPvM substances

Don't be surprised if inspectors ask for toxicological and ecotoxicological data, read-across justifications, supporting literature, or records validating supplier-provided data. A thin or missing scientific rationale is one of the fastest ways to invite a deeper investigation.

2. The SDS Sections That Draw the Most Scrutiny

Inspectors can review an entire SDS, but a few sections consistently get the closest look:

Section 2 — Hazard Identification. Inspectors check that hazard classes, categories, signal words, hazard and precautionary statements, and pictograms all match. Any gap between your classification and what's actually on the label is treated as a serious red flag.

Section 3 — Composition Information. This is where ingredient disclosure, concentration ranges, UFI codes, and the presence of hazardous constituents get checked for accuracy. Errors here can ripple downstream into poison centre notifications and broader compliance issues.

Section 11 — Toxicological Information. Authorities want evidence that your health hazard claims are backed by solid, available data — not just asserted.

Section 12 — Ecological Information. Environmental and persistence-related claims are getting more attention, particularly as EU CLP requirements continue to evolve.

It's Not Just the SDS — Your Marketing Gets Reviewed Too

Inspections increasingly extend well beyond the technical document set. Regulators are comparing your SDS against:

Website content

Marketing brochures

Product labels

Technical data sheets

Sustainability claims

Phrases like "non-toxic," "eco-friendly," or "safe"

The question they're really asking: does your public messaging contradict your own hazard classification, or create a misleading impression?

A few common red flags:

Calling a product "safe" when it's classified for serious health hazards

Making "environmentally friendly" claims with no supporting data

Sustainability messaging that isn't substantiated

Marketing copy that doesn't match what's actually in the SDS

This is exactly why regulatory, marketing, product stewardship, and EHS teams need to be talking to each other far more than they typically do.

The Gaps Inspectors Find Most Often

A handful of issues show up again and again during inspections:

Outdated SDSs. Many companies are still circulating SDSs that don't reflect current classifications, are missing newer hazard classes, carry stale supplier information, or cite outdated regulatory references.

Inconsistent documentation. Mismatches frequently turn up between SDSs and labels, SDSs and technical dossiers, marketing claims and hazard classifications, or supplier SDSs versus internally generated versions.

Weak data governance. Inspectors are paying closer attention to version control, document update workflows, how supplier data is managed, and internal review processes. Even a technically sound SDS can raise concerns if the governance behind it is shaky.

Gaps in employee training. Under OSHA HCS specifically, inspectors often check training records, whether employees actually understand how to use an SDS, how accessible the documents are, and whether workplace labeling practices hold up.

Why the Pressure Is Building

A few forces are converging to make inspections more demanding:

Expanding hazard criteria — new hazard classes mean more complex, more scientifically demanding classification decisions.

A push for transparency — regulators now expect companies to clearly show the reasoning behind hazard decisions, not just the conclusion.

More enforcement activity — targeted inspections, market surveillance, random audits, and supply chain verification are all on the rise.

ESG and sustainability pressure — environmental claims involving chemicals are facing sharper scrutiny than ever.

How to Get Ahead of It

Run internal SDS audits. Regularly check classification accuracy, label alignment, section-by-section consistency, and the strength of your supporting science.

Validate supplier data. Don't take upstream information at face value — confirm it against current regulatory requirements.

Build a claims review process. Every piece of marketing or sustainability messaging should pass through regulatory review before it goes public.

Tighten documentation governance. Solid version control, clear review workflows, well-organized scientific justification, and inspection-ready files go a long way.

Train across functions. Inspection readiness isn't a single department's job — it takes coordination between Regulatory Affairs, EHS, Product Stewardship, Marketing, and Quality.

The Bottom Line

As OSHA, EU CLP, and chemical regulations worldwide continue to evolve, inspections are only going to get more detailed, more data-driven, and more enforcement-focused. Companies that get ahead of this — aligning SDSs, classifications, labels, and public claims now — put themselves in a much stronger position to:

Lower chemical regulatory compliance risk

Sail through audits with confidence

Protect market access

Build supply chain trust

Safeguard brand credibility

EU CLP Just Got an Overhaul — Here's What It Means for Your Compliance Program

If you manufacture, import, or export chemicals into the EU, there's a new round of changes to the Classification, Labelling and Packaging (CLP) Regulation that deserves a spot on your radar — not your "someday" list.

The Headline Numbers

27 newly added harmonized classifications

16 existing entries revised

7 classifications retired as obsolete

A new hazard pathway for Endocrine Disruptors (ED)

PBT (Persistent, Bioaccumulative, Toxic) and PMT (Persistent, Mobile, Toxic) substances now formally folded into CLP's hazard classes

A transition period to May 1, 2028 for mixtures that were already on the market by May 1, 2026

Each of these has a direct line to your SDS documentation, your label artwork, and how your supply chain partners handle hazard communication.

A Shift From "Is It Dangerous Now?" to "What Does It Do Over Time?"

CLP started out focused on hazards you could observe quickly — burns, poisoning, flammability. This update leans further into the slow-building risks: hormonal disruption and environmental persistence.

On endocrine disruption, classifying a substance isn't a quick checkbox. It calls for a weight-of-evidence review that draws on toxicology data, validated studies, and a real dive into the existing literature.

On persistence and mobility, the regulation now distinguishes between four related risk profiles:

Category

What It Flags

PBT

Persistent, Bioaccumulative, Toxic

vPvB

Very Persistent, Very Bioaccumulative

PMT

Persistent, Mobile, Toxic

vPvM

Very Persistent, Very Mobile

A single substance hitting one of these categories can cascade into reformulation decisions across multiple products in a portfolio.

Three Ways Companies Lose Ground Here

SDS drift. A Safety Data Sheet that hasn't been touched since the last formulation tweak — or since a supplier silently updated their own hazard data — is a liability waiting to surface during an audit or a customs hold.

Blind trust in supplier SDS data. If the data coming from upstream suppliers isn't current, every classification built on top of it inherits the gap, often showing up downstream as inconsistent labels or supply chain compliance breaks.

Labels that lag behind classification. Updating the hazard assessment but not the pictograms, signal words, or precautionary statements on the physical label is one of the most common — and most avoidable — compliance failures.

Compliance Readiness Checklist

Screen your product portfolio for substances newly covered by this update

Verify classifications against the latest ATP and CLP hazard criteria

Refresh SDS Sections 2, 3, 11, and 12 as needed

Validate — don't just accept — supplier SDS data

Cross-check your chemical inventory against the revised list

Assess compliance at the mixture level, since component changes can shift the whole picture

Align label artwork with updated hazard communication rules

Train EHS, regulatory, and supply chain staff on the new requirements

Build a change-management process that catches the next update automatically

The Real Cost of Sitting on This

Delay tends to multiply the eventual bill: more regulatory exposure, more disrupted operations, rushed (and pricier) label redesigns, supply chain bottlenecks, and friction at export borders.

This isn't a one-time regulatory box to check — it's a prompt to rebuild how your organization handles hazard communication, SDS upkeep, and portfolio-wide compliance on an ongoing basis.

Organizations that act early can reduce risk, strengthen compliance resilience, and maintain uninterrupted market access in an evolving regulatory landscape.

Unsure how the latest CLP updates impact your products? Connect with Freyr to assess CLP compliance gaps and build a proactive roadmap for CLP Regulation readiness

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Good Manufacturing Practices: Building Global Food Safety Through Harmonized Standards

Good Manufacturing Practices (GMP) form the backbone of safe, consistent production in the food and dietary supplement industries. Rather than relying on testing finished products after the fact, GMP embeds safety and quality controls directly into every stage of manufacturing — from raw material handling to final packaging. This proactive approach covers sanitation, employee hygiene, equipment upkeep, process validation, storage conditions, recordkeeping, and traceability.

Why GMP Matters

A reliable GMP framework gives manufacturers the tools to:

Prevent contamination and product adulteration

Deliver consistent quality batch after batch

Track ingredients and products across the supply chain

Lower the risk of recalls and regulatory penalties

Earn and keep consumer trust

Compete effectively in international markets

Beyond the basics, mature GMP programs typically incorporate supplier vetting, environmental monitoring, process validation, and thorough documentation — all of which regulators around the world expect manufacturers to demonstrate.

The Push Toward Global Harmonization

As supply chains stretch across borders, regulators and industry groups have increasingly worked to align food safety rules, inspection methods, and manufacturing benchmarks. This harmonization effort aims to:

Create consistent manufacturing benchmarks worldwide

Streamline cross-border trade

Cut down on repetitive audits and testing

Strengthen food safety systems globally

Promote regulatory alignment between nations

When standards are harmonized, manufacturers can serve multiple markets without duplicating compliance work — and consumers gain confidence that products meet comparable safety thresholds no matter where they're made.

How Major Regions Approach GMP

United States The FDA oversees GMP for food and supplements through 21 CFR Part 117 (human food) and 21 CFR Part 111 (dietary supplements). These rules address sanitation, hazard analysis, process controls, labeling, documentation, and quality control. The Food Safety Modernization Act (FSMA) shifted the FDA's approach toward preventive, risk-based controls rather than reactive enforcement.

European Union EU food safety law is built around HACCP principles and hygiene regulations, with strong emphasis on traceability, allergen control, supplier qualification, and risk assessment. Many EU manufacturers layer GMP on top of international frameworks like ISO 22000 and FSSC 22000.

India The Food Safety and Standards Authority of India (FSSAI) governs food GMP requirements, increasingly drawing on Codex Alimentarius principles. Priorities include hygienic production environments, staff training, safe ingredient handling, sanitation, and documentation. India's expanding nutraceutical and food export industries have pushed faster adoption of internationally aligned practices.

Canada Health Canada and related bodies regulate food and supplement safety, focusing on product quality, ingredient traceability, accurate labeling, and robust quality assurance. Manufacturers targeting both US and Canadian markets often design their systems to satisfy both sets of requirements simultaneously.

Asia-Pacific Japan, Australia, and South Korea each maintain their own regulatory systems for food and health products, but most converge around risk-based quality management, hygiene controls, documentation, product validation, and supplier oversight. Australia's complementary medicines framework and Japan's food safety system are particularly noted for strong consumer protection standards.

International Standards That Reinforce GMP

Many manufacturers supplement national GMP rules with globally recognized certifications, including:

ISO 22000

HACCP

FSSC 22000

SQF (Safe Quality Food)

Codex Alimentarius

ISO 22000 in particular offers a widely adopted framework for identifying hazards and managing food safety risk across the supply chain, while Codex Alimentarius guidelines serve as a common international reference point for GMP implementation.

Where Harmonization Still Falls Short

Despite real progress, gaps remain:

Products get classified differently from one country to the next

Allowable ingredient levels vary by jurisdiction

Enforcement is inconsistent across regulators

Audit and inspection procedures differ

Documentation requirements aren't standardized

A single dietary supplement, for instance, might be treated as a food in one market and categorized entirely differently elsewhere — creating real headaches for companies trying to register products internationally.

The Payoff of Getting Harmonization Right

When harmonization works, manufacturers see tangible benefits: smoother operations, lower compliance costs, easier entry into new markets, stronger consumer trust, and reduced food safety risk overall. Consumers, in turn, gain confidence that products meet comparable safety and quality bars regardless of country of origin.

Closing Thoughts

GMP remains the foundation for safe, consistent, high-quality food and supplement production worldwide. Regulatory systems in the US, EU, India, Canada, and across Asia-Pacific each bring structured controls that reduce contamination risk and protect public health — even as their specific requirements differ.

As global trade networks grow more complex, the push toward GMP harmonization will only become more important for keeping food safety expectations consistent and compliance manageable. Companies that align their manufacturing practices with internationally recognized standards put themselves in a stronger position — better market access, tighter quality systems, and greater consumer confidence.

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