European Chemicals Agency’s REACH Regulation

• The European Chemicals Agency (ECHA) enforces REACH (Registration, Evaluation, Authorisation, and Restriction of Chemicals), a key regulatory framework in the European Union designed to ensure the safe use of chemicals and protect both human health and the environment. With over 20,000 chemicals registered under REACH, it is one of the most comprehensive chemical regulations in the world, impacting manufacturers, importers, and users across multiple industries. Let’s break down what REACH is, its core requirements, and how businesses can stay compliant.
  

  What is REACH?

  Implemented in 2007, REACH is a European Union regulation that stands for Registration, Evaluation, Authorisation, and Restriction of Chemicals. It applies to all chemical substances manufactured or imported into the EU, including those used in everyday consumer goods such as paints, textiles, and electronics. REACH obligates companies to identify and manage the risks associated with the chemicals they produce and market within the EU.

  The ECHA is the central authority responsible for managing REACH. It ensures that companies comply with their regulatory duties and maintains a public database of registered chemicals to promote transparency and safe practices.

  Core Elements of the REACH Regulation

  REACH consists of four main processes:

  1. Registration: Companies that produce or import chemicals into the EU in quantities over one tonne per year must register them with the ECHA. This process requires companies to provide extensive information about each substance, including its properties, hazards, and uses. Data submission is essential for assessing risks and ensuring proper handling and disposal.
  2. Evaluation: Once a substance is registered, the ECHA evaluates the provided data to determine whether it meets safety standards. If gaps in data or safety concerns are identified, the ECHA may require additional testing or impose specific conditions on the use of the substance.
  3. Authorisation: Some chemicals, especially those identified as Substances of Very High Concern (SVHC), require specific authorisation to be used within the EU. SVHCs are chemicals that may cause cancer, reproductive toxicity, or serious environmental harm. The ECHA periodically updates the Candidate List of SVHCs, and businesses must apply for authorisation to use these substances.
  4. Restriction: REACH restricts the use of certain hazardous substances in specific applications, products, or concentrations. The ECHA enforces restrictions on chemicals deemed too dangerous for general use or with severe environmental impacts. For instance, restrictions exist on heavy metals, certain phthalates, and persistent organic pollutants (POPs).

  Why REACH Matters for Businesses

  The REACH regulation significantly impacts EU-based manufacturers, importers, and downstream users of chemicals. Compliance with REACH is mandatory for selling or distributing products in the EU market. Here are some essential points businesses should consider:

  • Market Access: Only REACH-compliant products are allowed on the EU market. Companies failing to comply may face heavy penalties, including withdrawal of non-compliant products from the market.
  • Consumer Safety: By enforcing stringent controls on hazardous chemicals, REACH enhances consumer confidence and promotes the production of safer products.
  • Environmental Responsibility: REACH aims to minimize environmental harm by restricting or phasing out substances that accumulate in the environment, which aligns with the EU’s broader sustainability goals.

  Steps for Ensuring REACH Compliance

  To successfully comply with REACH, businesses should adopt the following strategies:

  1. Identify Chemicals Subject to REACH: Start by identifying all chemicals in your product range that are subject to REACH requirements. ECHA provides extensive guidelines on this, and companies may consult the ECHA’s database to verify if a chemical requires registration, authorisation, or restriction.
  2. Collect and Document Required Data: Accurate data is essential for the registration process. Gather information on each chemical’s properties, potential hazards, uses, and safe handling instructions. Working with certified laboratories can ensure data accuracy.
  3. Submit Registration Dossiers: For chemicals over one tonne per year, companies must submit a registration dossier to the ECHA. The dossier should include all data on safety, handling, and potential risks. Larger companies with in-house compliance teams often handle this process, while smaller companies may outsource it to REACH consultants.
  4. Monitor Updates to the SVHC List: The ECHA regularly updates the list of SVHCs. Businesses should monitor these updates and assess if any listed substances affect their products. If affected, companies may need to find alternative materials or apply for authorisation to continue using the substance.
  5. Implement Safety Procedures: Businesses must ensure that workers handling REACH-regulated substances are trained in proper handling, storage, and disposal practices. Implementing these safety measures protects employees and reduces liability for businesses.
  6. Stay Informed on REACH Changes: REACH is an evolving regulation with regular updates and changes. Subscribing to ECHA updates or working with a REACH consultant can help companies stay compliant and avoid penalties.

  Future Outlook and Challenges of REACH

  REACH is expected to grow in scope as the EU seeks to achieve its sustainability targets. The ECHA is continually adding new chemicals to the SVHC list, encouraging industries to shift toward safer alternatives. Challenges include the high costs associated with compliance, particularly for SMEs, and the complex nature of navigating regulatory requirements across the EU. However, the benefits of REACH compliance include improved market access, consumer trust, and alignment with global environmental standards.

 Contract Laboratory has helped many companies with their REACH Testing including the following projects:

• Italian cosmetic company needs consumer product safety laboratory for REACH compliance testing and toxicological tests for REACH registration, 1-10 tons of materials

• Company developing a new line of towels needs a consumer products laboratory for laundering test study: AATCC 96 testing (Dimensional Stability to Commercial Laundry). to show they can withstand frequent high-temp commercial laundry conditions at our customers’ large yoga studios. I need to reach below temperatures:wash = 170F (at least)dry = 190F (at least)

• EPA GLP Toxicology Laboratory needed for GLP Toxicity Study to for REACH dossier

• Toxicology Laboratory needed for REACH OECD polymer testing to OECD TG 118 (1996) method on phenolic syntans, melamine, dicyandiamide, naphthalene, chrome syntan, and tanning auxiliaries used for leather industry OECD TG 118 (1996) method is written on ECHA ?Guidance for polymers &monomers? booklet for GPC analysis. We are searching for laboratories that have certification for OECD TG 118 test.

• Analytical Chemistry Laboratory is needed for chemical analysis to determine the composition of butyl reclaimed rubber to be able to assess the registration requirements of the EU REACH Regulation.

• FDA Food Laboratory needed for medium-density polypropylene sheets testing to REACH, ROHS, and FDA food contact standards

• Asia Toxicology Laboratory environmental toxicology testing for CLP and REACH classification of hazardous materials to Chemical, Labeling, and Packaging (CLP) for EU REACH for hazards to GHS requirements for EU Safety Data Sheets

• Jewelry manufacturer & exporter needs REACH testing on glass. Please include tentative costs that may be incurred in this test and the approximate time taken to undergo this test & get the results.

• Men’s dress shoe manufacturer needs a laboratory for REACH testing and CPSIA testing. Materials are leather, EVA et TR.

• Detergent Manufacturer needs product safety toxicology laboratory for OECD tests: Skin irritation OECD439 Skin corrosion (human skin model test) OECD431 Eye irritation/corrosion OECD405 or Bovine corneal opacity and permeability OECD 437 Our concern is that we certain mixtures of detergents to eliminate corrosivity, based on the calculation method of the mixture classification according to CLP. Mixtures, which according to the original classification REACH based only irritating, often eye corrosive, in this case, the packaging symbol for corrosivity. Such labeling can be excluded if tests for eye corrosivity are excluded. The test must be performed within the SLP. Then I would like to ask about tests that relate to physical characteristics? E.g. determine the flash point, etc.

• Asia or Europe OECD, GLP Laboratory needed for REACH Registration Testing: Physicochemical and Toxicological testing for REACH Registration (EU Regulation for Chemicals)registration of the substance:? IUPAC Name: (butylamine)[[2,2′-thiobis[4-(1,1,3,3-tetramethylbutyl)phenolato]](2-)-O,O’,S]nickel ? CAS: 14516-71-3 ? EC: 238-523-3 ? The substance is solid. We would like to send us an offer covering all the endpoints of IUCLID (testing and/or bibliographic research and/or QSAR including). GLP certificate is necessary for the project. 1.4 Analytical information (substance identification) 4.10 Surface tension 4.11 Flash point Not applicable as solid 4.12 Auto flammability Waiving is possible depending on the melting point 4.13 Flammability 4.14 Explosiveness Waiving is possible 4.15 Oxidising properties Waiving is possible 4.17 Stability in organic solvents and identity of relevant degradation products 4.2 Melting point/freezing point 4.21 Dissociation constant. 4.22 Viscosity Not applicable for solids 4.3 Boiling point Waiving is possible depends from the melting point 4.4 Density 4.5 Particle size distribution (Granulometry) 4.6 Vapour pressure Waiving is possible 4.7 Partition coefficient 4.8 Water solubility 5.1.2 Hydrolysis Waiving is possible considering the use of the substance 5.1.3 Phototransformation in water Waiving is possible considering the use of the substance 5.2.2 Biodegradation in water and sediment: simulation tests Waiving is possible considering the use of the substance 5.2.3 Biodegradation in soil Waiving is possible considering the use of the substance 5.3.1 Bioaccumulation: aquatic / sediment Waiving is possible considering the use of the substance 5.4.1 Adsorption / desorption Waiving is possible considering the use of the substance 5.4.1 Adsorption/desorption screening study (HPLC method) Waiving is possible considering the use of the substance 5.6 Additional information on environmental fate and behaviour Waiving is possible considering the use of the substance 6.1 Aquatic toxicity Waiving is possible considering the use of the substance 6.1.2 Long-term toxicity to fish Waiving is possible considering the use of the substance 6.1.3 Short-term toxicity to aquatic invertebrates Waiving is possible considering the use of the substance 6.1.4 Long-term toxicity to aquatic invertebrates Waiving is possible considering the use of the substance 6.1.5 Toxicity to aquatic algae and cyanobacteria Waiving is possible considering the use of the substance 6.1.7 Toxicity to microorganisms Waiving is possible considering the use of the substance 6.2 Sediment toxicity Waiving is possible considering the use of the substance 6.3 Terrestrial toxicity Waiving is possible considering the use of the substance 6.3.1 Toxicity to soil macroorganisms except arthropods Waiving is possible considering the use of the substance 6.3.2 Toxicity to terrestrial arthropods Waiving is possible considering the use of the substance 6.3.3 Toxicity to terrestrial plants Waiving is possible considering the use of the substance 6.3.4 Toxicity to soil microorganisms Waiving is possible considering the use of the substance 7 Toxicological information 7.2.1 Acute toxicity: oral 7.2.2 Acute toxicity: inhalation 7.3.2 Eye irritation 7.5.1 Repeated dose toxicity: oral 7.5.2 Repeated dose toxicity: dermal 7.5.3 Repeated dose toxicity: inhalation 7.8.1 Toxicity to reproduction

• United States polymer laboratory needed for REACH compliance testing: project that has been approved that will use our reprocessed Copolymer Polypropylene black pellets. In order to move forward with this project, our customer is requiring us to provide them with a REACH compliance letter along with test data. I am in search of a company that will be able to provide this information for us.

• European Union Electrical Laboratory needed for RoHS testing and REACH Compliance testing: Could you perform analysis for substance detection as (reference: current list of SVHC published by the ECHA) on smart cards (SIM)? RoHS: Could you do also an analysis of the same article to confirm the RoHS compliance? If yes, what’s the lead time and fare?

• GLP Toxicology Laboratory needed for GLP REACH Toxicology Studies of one chemical substance: Two-generation reproduction toxicity study, EU B.35/OECD 416 Repeated dose (28 days) toxicity (inhalation), EU B.8/OECD 412 please specify a price for DRF, analytics, limit, and full study

• Materials Laboratory REACH testing of PSA masking films.

• Large Toy Manufacturer needs Toxicology Laboratory for Toy Testing: Toxicology Testing Toxicological Risk Assessment (TRA) Based on the ingredients or bill of substances to evaluate or assess any hazardous substances involved on the materials. The requirement should be referenced to EU REACH, SVHC,2009/48/EC, Washington Children’s Safe Product Act or California Green Chemistry Act, etc.

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NEED REACH REGULATION TESTING?

Are you a manufacturer that is exporting to, distributing, selling, or manufacturing in the European Union? If so, you will want to make sure your exporter, distributor, store, or manufacturer is in compliance with ECHA’s REACH regulation. So, call us at 1-855-377-6821 or Submit REACH Test Requests.