FDA Bans Red Dye No. 3 – What It Means for Consumers and Manufacturers
Erythrosine (E127), commonly known as Red Dye No. 3, is an organo-iodine compound derived from fluorine. It is a synthetic dye widely used to enhance the appearance of various food products, including candy, cakes, frozen desserts, cosmetics, and ingested drugs. Over the years, it became a popular ingredient across multiple industries, from food production to personal care. However, growing scientific research has raised concerns about its safety, particularly its potential carcinogenic effects. The primary reason for banning Red Dye No. 3 is its suspected carcinogenic potential. Studies suggest that this dye may disrupt thyroid function in humans, which plays a crucial role in regulating metabolism, growth, and development. As a result, regulatory authorities, including the FDA, have decided to take action to ensure consumer safety. The Role of Compliance in Consumer Protection The ban on Red Dye No. 3 underscores the importance of strict food safety regulations and product compliance. Adhering to these measures is not only about legal compliance but also about earning consumer trust, avoiding potential lawsuits, and ensuring high standards of safety and quality in food production. Compliance can be achieved through the following key areas: How Can Consumers Stay Informed? Consumers play a critical role in ensuring their own safety by staying informed and making conscious choices. Here are some steps to enhance awareness: What’s Next? These deadlines aim to ensure full compliance and the removal of the dye from all regulated products. With the ban on Red Dye No. 3 now in place, ensuring compliance with evolving regulatory standards has become more critical than ever. At ComplianceXL, we emphasize the importance of reducing reliance on synthetic colorants and preservatives to align with global safety regulations. While regulatory decisions may be beyond individual control, fostering awareness and guiding manufacturers toward higher safety standards can drive meaningful change. By staying informed and proactive, businesses can enhance compliance, protect consumers, and contribute to a safer marketplace.
How REACH Affects Non-EU Companies: What Exporters Need to Know
The European Union’s REACH Regulation establishes a rigorous framework to safeguard human health and the environment. For non-EU companies exporting chemical-containing products to the EU, compliance with REACH is mandatory. Failing to meet these requirements can lead to restricted market access, substantial fines, and damage to your reputation. If your business involves selling products in the EU, understanding REACH compliance is essential. This blog outlines the critical steps your company must take to successfully navigate the European market. Key REACH Requirements for Non-EU Exporters 1. Registration of Chemicals Non-EU companies are required to register any chemicals imported into the EU in quantities exceeding 1 ton per year. This involves providing the European Chemicals Agency (ECHA) with detailed information about the chemical’s properties, applications, and potential risks. 2. Appointment of an Only Representative (OR) To fulfill REACH obligations, non-EU exporters must appoint an Only Representative (OR) based in the EU. The OR acts as a liaison with ECHA, handling chemical registrations and ensuring compliance with all regulatory requirements. 3. Compliance for Imported Goods Manufacturers of finished products containing chemicals, such as electronics or clothing, must also ensure compliance with REACH. This includes registering any relevant chemicals and providing Safety Data Sheets (SDS) when required. 4. Notification of Substances of Very High Concern (SVHCs) If your products contain Substances of Very High Concern (SVHCs) in concentrations above 0.1%, you are obligated to notify ECHA and inform your customers. SVHCs include carcinogenic or toxic chemicals that pose significant risks to human health and the environment. 5. Restrictions and Authorizations Certain hazardous substances are restricted under REACH, while others may require explicit authorization for use. Exporters must ensure that their products do not contain prohibited or restricted substances unless authorized. Why Compliance is Crucial for Non-EU Companies Failure to comply with REACH can have serious consequences, including: Steps Non-EU Companies Can Take to Ensure REACH Compliance To access the EU market seamlessly and avoid compliance-related penalties, follow these steps: 1. Identify Your Chemicals Assess your products to determine the chemicals they contain. Verify whether these chemicals are registered under REACH. For unregistered substances, either complete the registration process or appoint an OR to manage it on your behalf. 2. Appoint an Only Representative Designate an OR within the EU to oversee compliance activities, including chemical registration and communication with ECHA. 3. Submit Required Declarations to ECHA Collect comprehensive data about your chemicals and submit it to ECHA for registration. This includes details on their properties, uses, and potential risks. 4. Update Safety Data Sheets (SDS) Ensure that SDS for hazardous substances are regularly updated to reflect current compliance requirements. 5. Stay Informed on REACH Updates Monitor changes to REACH regulations, particularly regarding new substances added to the SVHC list or updated restrictions. Staying informed helps maintain ongoing compliance. 6. Seek Professional Guidance Consult regulatory experts or legal professionals specializing in REACH compliance to better understand and fulfill your obligations. Adhering to REACH is essential for non-EU companies aiming to access the European market and avoid penalties. With ComplianceXL as your compliance partner, you can simplify the process by leveraging our expertise in appointing an Only Representative, registering chemicals, and ensuring all safety and labeling requirements are met. Our tailored solutions help businesses thrive in one of the world’s most regulated yet lucrative markets. Proactive compliance, supported by ComplianceXL’s services, ensures smooth market entry and sustained growth. FAQs: 1. Does REACH apply to non-EU companies? Yes, non-EU companies must register chemicals with ECHA if they intend to import more than 1 ton per year. Registration applies to both pure chemicals and substances within finished products, such as electronics, toys, and clothing. 2. Can I export products to the EU without complying with REACH? No. Non-compliant products are likely to be denied entry into the EU market. Failure to adhere to REACH can result in fines, export bans, and legal action. Only compliance ensures market access.
GHS Revision 8 and Major Changes
The UN Economic Commission for Europe has published 8th revised edition of GHS . The electronic version is still not released and is expected to release by end of September 2019. The major changes in the new version are New classification criteria for Chemical under pressure & aerosols New Hazard category A new annex on dust explosion hazards Added Precautionary pictogram Revised precautionary statements New provisions for the use of in vitro/ex vivodata and non-test methods to assess skin corrosion and skin irritation New labelling examples for sets or kits Editorial revision of Sections 2 and 3 of Annex 3 Major changes are summarized below: 1. Classification criteria change for aerosols According to table 2.3.1, aerosols are to be classified in one of the three categories and it will be based on: their flammable properties their heat of combustion if applicable, test results from the ignition distance test, the enclosed space ignition test and the aerosol foam flammability test, performed in accordance with subsections 31.4, 31.5 and 31.6 of the United Nations Recommendations on the Transport of Dangerous Goods, Manual of Tests and Criteria Listed below are the new aerosol classification criteria Category 1: Any aerosol that contains ≥ 85% flammable components (by mass) and has a heat of combustion of ≥ 30 kJ/g or Any aerosol that dispenses a spray that, in the ignition distance test, has an ignition distance of ≥ 75cm or Any aerosol that dispenses a foam that, in the foam flammability test, has: a heat of combustion of ≥ 20cm and a flame duration of ≥ 2 seconds a flame height of ≥ 4cm and a flame duration of ≥ 7 seconds Category 2: Any aerosol that dispenses a foam that, based on the results of the aerosol foam flammability test, does not meet the criteria for Category 1, and which has a flame height of ≥ 4cm and a flame duration of ≥ 2 seconds or Any aerosol that dispenses a spray that, based on the results of the ignition distance test, does not meet the criteria for Category 1 and which has: a heat of combustion of ≥ 20 kJ/g a heat combustion of < 20 kJ/g and an ignition distance of ≥ 15 cm 2. a heat of combustion of < 20 kJ/g and an ignition distance of < 15cm along with either, in the enclosed space ignition test: a time equivalent of ≤ 300 s/m3 a deflagration density of ≤ 300 g/m3 Category 3: Any aerosol that contains ≤ 1% flammable components (by mass) and that has a heat of combustion of < 20 kJ/g or Any aerosol that contains > 1% (by mass) flammable components or which has a heat of combustion of ≥ 20 kJ/g but which, based on the results of the ignition distance test, the enclosed space ignition test or the aerosol foam flammability test, does not meet the criteria for Category 1 or Category 2. 3. New Hazard category: Chemical under pressure Chemicals under pressure are liquids or solid substances/mixtures, pressurized with a gas at a pressure of 200kPa (gauge) or more at 20 o C in a pressure receptacle other than aerosol dispensers and which are not classified as gases under pressure. Below listed are the classification criteria for chemicals under pressure. Category 1: Any chemical under pressure that contains > 85% flammable components(by mass) and has a heat of combustion of > 20 kJ/g. Category 2: Any chemical under pressure that; 4. contains >1% flammable components (by mass) and has a heat of combustion <20kJ/g or that; 5. contains <85% flammable component (by mass) and has a heat of combustion of <20kJ/g. Hazard statements and pictograms for chemicals under pressure are listed as below. Hazard category Symbol Signal word Hazard statement Symbol 1 Flame & gas cylinder Danger Extremely flammable chemical under pressure. May explode if heated. 2 Flame & gas cylinder Warning Flammable chemical under pressure. May explode if heated. 3 Gas cylinder Warning Chemical under pressure. May explode if heated. 6. New Precautionary Pictograms for “Keep out of Reach of Children” The following pictograms from AISE and JSDA to convey precautionary statement “Keep out of reach of children”. 7. New Labeling Example for Sets or Kits A new example for labelling sets or kit is provided in example 10 appended to Annex7.Small removable inner containers are present in a kit/set. Inner container label The following minimum information mustbe included on the label of each hazardous substance or mixture. Product identifier, and an identifier for each substance or mixture matching the identifier used on the outer packaging label and SDS for that substance or mixture, eg “Reagent 1” and “Reagent 2”. Pictogram(s). Signal word. The statement “Read full label”. Supplier identification (ie name and telephone number). Outer packaging label In addition to the kit identifier, all the required GHS label elements must appear on the outer packaging for each hazard mixture/substance. 8. Dust explosion hazard -A new Annex Annex 11 – Guidance on Other Hazards Not Resulting inClassification, will provide guidance on the identification of dust explosion hazard and need for assessment of risk, prevention, and hazard communication. 9. Minor changes – with regards to precautionary statements for skin irritation and serious eye damage Skin corrosion/irritation- classification to be mentioned as category 1,if the available data is limited & subcategories 1A, 1B or 1C cannot be assigned or as per the competent authority requirement (3.2.2.1.1.2). Serious eye damage/eye irritation-classification category to be mentioned as 2, where the available data is not enough for further categorization, or where the competent authority does not require categorization into 2A or 2B (3.3.2.1.2.1).