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Launching in France? Get your FREE guide to DGCCRF compliance, food supplement labeling, registration & EU market entry in 2025. Download now!

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Freyr is a global Regulatory Solutions and services company offering services across the entire regulatory value-chain for Pharmaceuticals, Medical Devices, Biotech, Biosimilars, Consumer Healthcare companies across the globe.

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Freyr is a global Regulatory Solutions and services company offering services across the entire regulatory value-chain for Pharmaceuticals, Medical Devices, Biotech, Biosimilars, Consumer Healthcare companies across the globe.

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Need help with K-BPR or K-REACH in South Korea? Get expert guidance on biocidal product approval, documentation & regulatory compliance from Freyr.

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Compare NDIN and GRAS Regulatory pathways with our clear infographic. Learn FDA requirements for food supplements & how to choose the correct route to compliance.

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Stay CLP compliant with expert tips on hazard classification, labeling, SDS, PCN. Ensure EU chemical safety with Freyr’s regulatory support. Contact us now

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Explore FDA 2025 “healthy” claim rule how it impacts food labeling. Get expert advice on reformulation, labeling updates, FDA compliance strategy

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Explore our PPWR infographic to meet 2025 packaging goals. Learn recyclability, EPR, labeling steps & act now to stay compliant. Download today!

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Learn how to submit your CNF to Health Canada. Our infographic covers cosmetic product notification, labeling, & compliance for smooth market entry in Canada.

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Explore our essential ESG compliance checklist covering governance, risk, DEI, supply chain traceability, and reporting standards like CSRD, GRI & TCFD.

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REACH vs. TSCA: Comparing EU & US Chemical Regulations

Chemical regulations such as the EUS range and the US TSCA play an important role in ensuring the security of people and the environment. Both frameworks aim to manage chemical risks, but differ in their job, who they apply to, and what they have to do to comply with. Scope and reporting Rang (Chemical Registration, Evaluation, Approval, Restrictions) applies to all chemicals manufactured or imported  in amounts of more than one tonne  per year to the EU. It also covers  finished products and mixtures of chemicals. The TSCA (Toxic Substance Control Act) applies to most industrial chemicals in the United States, except for products such as pesticides, foods, and drugs. In contrast to Reach, TSCA focuses more on new chemicals or new uses of existing substances. Registration requirements The registration process requires the company to register the substance before it can be sold by the European Chemical Agency (ECHA). Detailed technical documentation with certainty, use and risk is required. If it is not registered, it cannot be sold. This is "no data, no market management." According to TSCA requirements, businesses must submit a preparatory advertisement (PMN) to  the U.S. Environmental Protection Agency (EPA) 90 days prior to the introduction of new chemicals. The EPA may assess risk, impose restrictions or deny approval. Chemical risk assessment and testing The company is responsible for certifying that the  chemicals are safe. Hazard testing is stipulated based on public exchange of production volumes and  key data. Special approval may be required due to high risk of carcinogenicity and persistent contaminants. In contrast, EPAs under TSCA assess risk. The updated TSCA Act requires that if the EPA represents an inappropriate risk, it must check and act on chemicals already in use. However,  unless the EPA requires this, the tests are not automatically required. Substance restriction and enforcement Reach has several regulatory lists.  List of candidates for highly problematic substances (SVHC) Approval List (Appendix XIV)Restrictions List (Appendix XVII) The TSCA has a central inventory of acceptable chemicals, which adds restrictions per case. There is no equivalent to achieving the approval process. Enforcement is also different. Reach is administered by the ECHA, but enforcement is handled by all EU member states. Therefore, ECHA registration is essential for businesses to sell their products in the EU. The TSCA is enforced by the EPA and can impose strong fines and penalties for violations. Suppliers and compatibility Reach compliance requires a safety data sheet (SDS), product identification, and a notification regarding poison centres. Non-EU companies must appoint a single representative (OD) to manage conformance. TSCA Compliance Compliance requires you to authenticate compliance, report usage, and keep a record for at least five years.  Global Compliance Strategy Although both systems are intended for chemical security assessment, Reach is an industry operator and data-related, TSCA is governed by the government and focuses on EPA reviews. Companies working in both markets need to manage a variety of compliance strategies. Many choose to meet Reach's higher standards  to simplify access to the global market. Freyr supports companies with reach and TSCA compliance, ensuring chemical registrations and regulatory permits are secured in both the EU and US markets.

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Explore how EU’s PPWR affects food & supplement packaging, recyclability, and labeling. Learn how to achieve compliance and avoid EU market entry risks.

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Discover how Extended Producer Responsibility (EPR) supports the circular economy by enforcing product lifecycle accountability and packaging compliance.

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EU SUP Directive: Key Challenges & Business Impacts

The European Union Directive (SUP)  was introduced to reduce the environmental impact of plastic waste, particularly in the marine environment. While marking key steps into sustainability and circular economy packaging, implementation of directives in sectors of various sectors presents several challenges, especially for  those using plastic materials for packaging, product design and assurance of EPR compliance. What is the EU SUP directive? The EU SUP Directive covers the top 10 disposable plastic objects most seen on European beaches, including cutlery, plates, straws, stir-fry and certain food containers. The EU ban includes the ban on some objects, the goal of reducing the consumption of other objects, identification, sensitization campaigns, and the requirements for  extended producer responsibility (EPR). Important issues for businesses 1. Material performance and testing Companies replacing prohibited plastics with alternatives must ensure that these alternatives meet EU composting and recyclability standards, such as the compostable plastic EN 13432. However, many alternatives have been exposed to issues relating to performance and regulatory approval issues. For example, materials can meet technical composting, but cannot function well under real conditions. This creates uncertainty regarding product liability. 2. Limited availability of alternatives The supply of scalable and compliant  plastic alternatives is still limited. This shortage affects sectors such as food service, personal care and consumer goods, which rely on materials such as plastics for hygiene and function. With increasing demand, competition for compliant materials is expected. 3..The ambiguity of regulations and differences between nations Although the guidelines are in the EU, each member state has its own interpretation and assertion mechanisms, leading to inconsistent application. Companies working in several countries need to adapt their packaging adaptation strategies to increase costs and complexity. 4.. Economic impacts and redesign of costs Migrating to SUP-compliant products requires redesigning existing packaging, updating labeling, testing new materials, and investing in new manufacturing technologies. These changes can be particularly difficult for small and medium-sized businesses (small and medium-sized businesses). This can result in short supply of resources to adapt quickly. 5. Product Category Limitations Certain product categories such as plastic straws, stir-fry and polystyrene containers are mocks, even if they are used in niches and essential applications. Companies need to develop their products or packaging completely without a transition period in some cases. Conclusion Regulations on the individual birth of plastics reflect the growing global concerns about plastic pollution and lead to a clear path to sustainable product design. However, it also poses considerable compliance and operational challenges for the SUP guidelines. Companies must be proactive, informed and flexible in their responses. With proper regulatory support, businesses can transform these challenges into innovation options and lead them to the future of plastics. Freyr helps businesses address the challenges of these SUP guidelines by providing end-to-end regulatory support. From identifying approved alternatives and adjusting material compatibility tests to marking and document assurance, Freyr simplifies  complex transition processes. Experts also help prepare regulatory submissions and manage cross-border compliance, helping businesses adapt quickly and cheaply.

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Register cosmetics in Costa Rica easily. Learn the MOH process, compliance steps, and how Freyr Solutions supports your beauty product launch.

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REACH Compliance: Requirements for EU Chemicals

If you want to place your chemical products in the European market, it is important to record your reach (registration, ratings, permits, chemical restrictions). This range ensures that chemicals are safely produced and used in the EU. Reach the chemical company's compliance checklist For businesses, this means meeting strict requirements for scope, security documentation and ongoing compliance. Here you need to know: Compliance Area What that means Substance Registration All chemicals processed in amounts of 1 ton/year must be registered with the European Chemicals Agency (ECHA). Technical documents must be submitted. Property Insurance Data Sheet (SDS) For dangerous chemicals, companies must create SDs that include classifications of danger, emergency measures and environmental impacts in the official EU language. Once you reach SVHC and reach an automated process substance of very high interest (SVHC), use of use may be required. Companies  also need to provide these chemicals to consumers and  supply chains. Limiting hazardous substances ensures that chemicals perform the ranges or prohibitions listed within XVII (lead, phthalate, asbestos). If range testing requirements and safety assessment data are not sufficient, additional toxicological and environmental testing may be required as our focus is on using alternative methods to reduce animal testing. A single representative is required (or) for achieving the importer's obligations and compliance with the supply chain of non-EU companies. Importers must ensure compliance with scope when  chemicals are brought into the EU, and downstream users must also adhere to them.CLP classification, labeling and packaging chemicals must be classified, marked and packaged according to  CLP regulations, including hazard pictograms, signal words, and precautions. Toxic centres should report toxic mixtures. The label must contain clear formula detection (UFI) for easy identification in emergencies.  Market surveillance and enforcement of national authorities monitor compliance. Failure to comply will result in fines, prohibitions, or legal consequences. Why compliance is important When you want to ensure that your product meets the requirements of the range, it's not just about escaping the difficulties. This is important to gain trust in the market, protect your health and security, and ensure long-term access to the market. If not certain, it could lead to serious financial and reputational damage, delays in products, and even market bans. Meanwhile, this range demonstrates commitment to key values ​​of security, transparency and sustainability for both consumers and investors. Diploma Understanding the scope can be complicated, but it does not have to be done alone. Freyr offers compliance services that allow you to manage all aspects of reach compliance. Keep regulations up to date so that you can focus on the growth of your company in the EU market. Guide yourself through the process to ensure smooth and compliant access to the market. To start your reach compliance trip, contact Freyr.

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Understanding TSCA Compliance: Impact on the Chemical Sector

In today's strictly regulated landscape, compliance is not just a legal obligation, it is a competitive advantage. The Toxic Substance Control Act (TSCA), controlled by the US Environmental Protection Agency (EPA), regulates the entire life cycle of US chemicals from production and compliance with production and disposal chemical imports. The bar grew up from the pivotal 2016 to Frank R. Lautenberg. Chemical companies  now maintain higher standards of transparency, security and accountability, especially when introducing new materials. Understanding and setting up TSCA development requirements is not just averting punishment. It's about unlocking long-term operational resilience and staying true to the market. tsca at a glance Main compatibility areas What does that mean to you? TSCA Chemical Inventory and Registered All chemicals must be listed in the TSCA Stock List or in the EPA Pre-Approval. TSCA risk assessment substances are marked as high or low priority. There is a cross-preality review. Company TSCA reporting requirements and obligations must submit detailed usage and exposure data in accordance with CDR rules. Restrictions and prohibitions on dangerous substances may be restricted, turned off and completely prohibited.Imports certified imports require a TSCA declaration of conformity to remove customs. Pricing and Cost Effectiveness The TSCA application is equipped with EPA rates and testing costs, and must be guided to your budget. TSCA Compliance Flow - New Chemical Approval Start with  new chemicals Check your TSCA inventory If the chemical is listed, it can continue to be produced or imported. If no chemicals are listed, change to step 3.  The PMN environment process involves sending a preparatory display (PMN) to the EPA Must be submitted at least 90 days prior to production or import. EPA rates PMN A 90-day risk assessment will be conducted to assess health and environmental risks. EPA decision If approved, drive under specified conditions or import. If it is not approved, you may need to: Enter additional data or test results Change the substance or  intended use Implement risk management measurements All EPAs support the supported limits before launching the market. Latest examples of TSCA implementation material TSCA Campaign Selected asbestos in most applications The use of PFA restriction is limited in several formulations Methylene chloride fades to consumer colour NMP Limited for Home Cleaning Products TSCA Compliance: Risk and Reward A non-violation with the TSCA can lead to: Customs waste and product delays Civil Penalties and Official Measures Reputation and company risks However, compliance also offers strategic benefits such as smoother market access, better trust for investors, and managing sustainability. Diploma Compatibility of TSCA  can be complicated, but it doesn't have to be overwhelming. Freyr supports chemical manufacturers and importers with its TSCA compliance services. TSCA registration and preparation steps Risk Assessment Document Data Reports and Exam Preparation Whether you launch a new product or guarantee an existing material, we will help you stay submissive and competitive. Navigate the TSCA regulations. Switch schools free of charge.