Deciphering REACH: Annex 14, Annex 17, and SVHC Distinctions
To oversee and manage the utilization of chemicals in the European Union (EU), the EU established the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) legislation. Enacted on June 1, 2007, REACH aims to ensure a high standard of protection for both the environment and public health while simultaneously enhancing the competitiveness of the European chemicals sector. In our exploration of “Meeting REACH requirements,” we identified three pivotal lists that EU manufacturers must be mindful of to ensure comprehensive compliance: 1. Substances of Very High Concern (SVHC): Chemicals with potential hazards to the environment or human health are listed on the SVHC or Candidate Lists. These substances undergo further scrutiny and may end up on the Authorization List. Manufacturers, importers, and downstream users have specific obligations if a substance is included on the Candidate List. If an SVHC is present in their product at a concentration exceeding 0.1% by weight, they must report it to the European Chemicals Agency (ECHA). The purpose of this list is to monitor and prioritize compounds for future evaluation and regulation. The SVHC list is revised biannually, necessitating businesses to reassess product compliance and request data from suppliers to meet REACH standards. 2.The Authorization List (Annex XIV): Annex XIV of REACH, known as the Authorization List, comprises substances of very high concern (SVHC) posing serious risks to the environment or human health. Unless a specific exemption applies, companies using substances listed on the Authorization List must obtain authorization from ECHA before their use. The primary goal of the Authorization List is to phase out or restrict the use of hazardous substances gradually while promoting safer alternatives. 3.The Restriction List (Annex XVII): The Restriction List, or Annex XVII of REACH, imposes specific restrictions on the production, marketing, or use of hazardous chemicals. These legally binding restrictions aim to mitigate risks associated with substances, products, or processes. Restrictions may take the form of usage prohibitions, concentration thresholds, or other controls. In summary, the REACH legislation assigns distinct responsibilities to these lists: Substances of very high concern are identified on the Candidate List, triggering additional scrutiny. The use of chemicals listed on the Authorization List requires specific authorization. The use of certain hazardous substances is legally restricted according to the Restriction List. These lists collectively govern the use of chemicals in the EU, ensuring that businesses dealing with these substances adhere to relevant REACH requirements and regulations. With over 20 years of regulatory experience, ComplianceXL provides ongoing assistance to companies seeking compliance with REACH regulations, facilitating efficient risk assessments, compliance management, and accurate reporting for improved regulatory operations.
Hexavalent Chromium in Focus: Get the latest EU RoHS Exemptions
Numerous hazardous substances are prohibited in electrical and electronic equipment (EEE) under the EU RoHS directive, aimed at safeguarding the environment and human health. RoHS 2.0 replaced the original RoHS directive (2002/95/EC) in 2003, following its recasting in July 2011 (2011/65/EU). Member states will commence applying the new exemptions from September 1, 2023. However, specific applications or industries are granted exemptions from RoHS requirements, which come with designated expiration dates. To ensure complete adherence to regulations, industries must identify suitable alternative technologies or materials during the exemption period. On October 28, 2022, the European Commission introduced exemptions to the EU RoHS Directive, affecting businesses that utilize hexavalent chromium. These exemptions permit limited use of hexavalent chromium in certain applications, despite its hazardous nature. To maintain compliance with the directive, companies must both abide by the regulations and adhere to the outlined conditions of the exemptions. For a detailed list of changes, refer to: COMMISSION DELEGATED DIRECTIVE (EU) 2023/171 The updated “9(a)-III” exemption now pertains to Category 1 Large Appliances and remains valid until December 31, 2026. This exemption allows the utilization of up to 0.7 percent by weight of hexavalent chromium as a corrosion inhibitor in the working fluid of carbon steel closed circuit gas absorption heat pumps. Member states will begin accepting applications for the new exemptions from September 1, 2023. It’s crucial to note that information concerning RoHS exemptions may evolve with time, potentially leading to the addition of new exemptions or the revision of existing ones. Manufacturers and businesses impacted by RoHS should consistently monitor the latest updates from the European Commission to ensure ongoing compliance. This vigilance ensures alignment with the current regulations. Exemptions within the EU RoHS Directive affecting companies using hexavalent chromium were introduced by the European Commission (EC) on October 28, 2022. At ComplianceXL, our dedicated team remains committed to delivering the latest news on EU RoHS and regulatory compliance that could influence your business operations. We furnish dependable information and insights, empowering you to remain informed and make well-informed decisions. Furthermore, our team is poised to assist you in devising strategies for complete compliance with all relevant regulations.Contact us today for more information!
SDS’s indispensable role in the air transportation industry
A safety data sheet is a document that provides safety information about a product. They are a complete source for all the information you may need or want to know about a chemical product you may need or want to know. Globally, they are used to transmit detailed information about a chemical product, including how it should be used, what effects it has, how to protect against those effects, what regulations apply to chemicals, and other information about how they should be used. There are several challenges involved in transporting hazardous materials. To meet numerous safety restrictions limiting free passage, it is necessary to move dangerous loads with great care and caution. In accordance with the Dangerous Goods Regulations (DGR) manual of the International Air Transport Association (IATA), dangerous goods include articles or substances that pose a threat to health, safety, property, or the environment, and which are listed on the IATA Dangerous Goods Regulations list. Some examples of dangerous goods are aerosols, lithium batteries, and infectious substances. A Safety Data Sheet provides detailed information about a substance or mixture used at work. Using it, both employers and workers can learn about safety precautions and hazards. SDS acts as a reference source for hazardous chemicals management in the workplace. SDSs provide all the information about chemical classification in air cargo, regardless of whether it is restricted. It must be prepared and accepted according to IATA dangerous goods regulations if it is restricted and classified as a dangerous goods shipment. The airline must receive the proper and trusted SDS attached to the shipping documents if the chemical is not restricted. The airline follows this policy to ensure the safety of its cargo. The SDS includes all relevant transportation information in section 14. The UN Number identifies hazardous substances (e.g., explosives, flammable liquids, toxic substances, etc.). The UN Proper Shipping Name describes the hazards associated with the goods. According to transport regulations, all dangerous goods must be assigned to a Proper Shipping Name. A transport hazard class is determined by its most significant hazard. Depending on the level of hazard, a packing group number will be assigned (e.g., I, II, III, 1A, 1B, and 1C). To determine whether a substance is an environmental hazard, it is necessary to determine whether it is a marine pollutant. Users should be alerted to any special precautions in this section. There is additional safety and hazard information regarding bulk shipments. As required by regulations, safety data sheets help to keep safety data sheets up to date. As a result, compliance issues and costly fines can be avoided. A SDS on hand always provides workers with the resources they need to handle materials safely and reduce their risk of an accident. Workplace illnesses and injuries caused by chemical sources are reduced. To protect themselves from hazardous chemical exposures and to work safely with chemical products, employers and employees need to have information contained on SDS. Industries and companies benefit greatly from safety data sheets. Whether you are a small business or a large corporation, everyone needs SDS. SDS are required for manufacturing, processing, importing, exporting, and transporting substances. In reducing risks and mitigating accidents, this framework is very useful. Compliance XL offers a wide range of SDS services to assist organizations with effective SDS management. Our experts will ensure there are no accidents during storage and disposal. Get hassle-free SDS services from Compliance XL Today. Our compliance services include SDS authoring, REACH, RoHS, and Conflict Minerals compliance. FAQs: 1.What are the 16 sections of a Safety Data sheet? It includes the identification of hazards, their composition, first aid, firefighting, accidental release measures, handling and storage, exposure controls/personal protection, physical and chemical properties, stability and reactivity, toxicological information, ecological information, disposal considerations, transport information, regulatory information, and other information. 2.What is the difference between MSDS and SDS? Material Safety Data Sheet (MSDS) does not have hazard statements, signal words, pictograms, ingredients, and percentages of mixed chemicals. SDS is more standardized with 16 sections in a regulated format. 3.What is IATA? The International Air Transport Association (IATA) represents the world’s airlines. Supports many aviation activities and contributes to the formulation of aviation policy.
Persistent organic pollutants (POPs): everything you need to know
There are many instances when harmful chemicals travel and cause adverse effects far from their original places of production and use. A well-known example is persistent organic pollutants (POPs), which can travel long distances and reach remote locations. However, many of these devices contain components and materials that can pose health and environmental risks. As part of this blog post, we will explore the sources and risks of POPs in electronic devices. Various products include POP (Persistent Organic Pollutants) materials such as circuit boards, casings, cables, batteries, and other electronic device components. These materials can find their way into the environment during both manufacturing and disposal processes, potentially causing environmental contamination. Low codes are determined by the chemical makeup of waste, as well as whether hazardous waste controls or persistent organic pollutants (POPs) apply. WEEE can be categorized as follows: Hazardous waste – waste containing hazardous chemicals above certain concentrations. POP waste –If the chemicals are POPs and exceed certain concentrations. A POP is an organic compound that has toxic properties, persists in the environment, accumulates in food chains, and poses a health and environmental risk. As a result of their persistence, these chemicals have the potential to be transported far from their source through air, water, and migratory species. The release of POPs into water bodies or the deposit of POPs in soil can pollute these environments. As a result of this contamination, aquatic life, soil organisms, and ultimately humans are at risk of consuming contaminated water or crops. How to safeguard society and Environment from POP? The prevention, control, and responsible management of persistent organic pollutants (POPs) are vital for protecting society and the environment. These measures can protect society and the environment from the harmful effects of POPs. Hazardous substances can be reduced by adopting eco-design principles. Manufacturers, policymakers, consumers, and recycling facilities must collaborate to share knowledge, best practices, and innovations in reducing and eliminating POPs in electronic devices. The government should enact and enforce regulations restricting or banning POPs in electronic devices. Consumer demand for safer and more sustainable electronic devices can be increased by increasing public awareness about POP risks. Developing safer alternatives to POPs commonly used in electronic devices should be the focus of research and development. Population declines and biodiversity loss can result from POPs negatively impacting ecosystems and biodiversity. Aside from affecting human life, it can also cause cancer, developmental disorders, neurological effects, hormonal disruptions, resulting in thyroid problems, impaired immune function, and metabolic problems. There is no doubt that POPs have a significant, and widespread, impact on human health and the environment as a whole as a result of their widespread distribution and use. As a result of our inability to reduce the production, use, and release of pollutants that cause damage to human health and to ecosystems, it is essential that we take steps to protect both human health and ecosystem integrity. ComplianceXL offers specialized solutions to help organizations effectively manage POP-related documentation. The services we provide include consulting, supplier engagement, and more, all to address the challenges posed by Persistent Organic Pollutants. To learn how we can help your organization ensure compliance and safeguard the environment, contact our Material Compliance Specialists today. FAQs 1. What are the persistent organic pollutants in e-waste? E-waste contains numerous toxic chemicals including metals such as lead, cadmium, mercury, and nickel, and organic compounds such as flame retardants, chlorofluorocarbons, (PAHs), polybrominated diphenyl ethers (PBDEs), (PCDD/Fs).
Did you know? ECHA has identified 300 chemicals as candidates for regulatory action
On 21 April 2021, ECHA published its third report on Integrated Regulatory Strategy. It provides latest information on Agency’s work regarding the identification and management of chemicals that are hazardous. It aims at accelerating data generation, identifying of groups of substances of concern, and regulatory action. Last year, ECHA addressed the chemical with similar structure in groups instead of each chemical individually. This increased the total number of chemicals assessed in 2020 to 1900.As per the report, RMOA (Regulatory management option analysis) it was concluded that 290 substances were identified for further regulatory risk management. These chemicals require more data to be submitted and hazard confirmation before taking any regulatory action. These substances include potential CMRs, few potential EDs, PBTs and respiratory sensitizers. The conclusion will be shared and publicly available on ECHA’s website by end of 2021. Under EU legislation, harmonized classification is a prerequisite for risk management actions. Over 100 chemicals identified would warrant harmonized classification, but still not picked up by the authorities. Lack of harmonized classification can cause a delay in risk management action by the authorities, The progress is made in clarifying the need for regulatory action of substances registered above 1 ton. ECHA recommend that, while the agency continue to work on optimizing group approach for substances: Member states, without delay should initiate regulatory risk management for the substances that require further action. Member states should collaborate with each other to maximize their outcome of work. Industries should make use of the developed programs to help them to review and update the REACH Dossiers. Updates must be done proactively, even before authorities take regulatory actions. ECHA aims to provide clarification by 2027 for which registered substances are a high priority for regulatory risk management or data generation, and which are currently a low priority for further regulatory action. Talk to one of our global compliance specialist today!
SCIP– A new data base introduced by ECHA
ECHA plans to maintain a database that contains the information on Substances of Concern In Articles or Products. The guideline regarding SCIP database requirements were released on 9th Sep 2019. This information will be available to waste operators and consumers. The idea is to improve the transparency on hazardous substances throughout the lifecycle of an article, including the waste stage. Under the Waste Framework Directive, 2008/98/EC, companies that supply articles that contain SVHC candidates, in concentration above 0.1%w/w, will have to submit enough information to allow safe use of those products/articles to ECHA. The database takes the requirements of Article 33 of the REACH Regulation and provides a mandatory platform for submission of the information as from 5 Jan 2021. Below are the main objectives of database. Decrease hazardous waste generation, by providing substitution for SVHCs. Make information transparent for waste treatment operations. Allowing monitoring use of SVHC in articles and initiating appropriate actions on the overall lifecycle of the products. It includes waste stage also. The information available in SCIP database will help waste operators to understand the hazardous substance, so that material streams can potentially be “cleaned” before recycling and reused in the production of new articles and thus ensure a true and safe circular economy. In addition, the increased transparency on the presence of hazardous substances will help consumers to make better choices when purchasing products and provide information on the best usage and disposal of such articles. ECHA requires information from below categories to SCIP database. EU producers and assemblers EU importers EU distributors, who place articles/products directly to the market. Retailers and other supply chain supplying articles/products directly to consumers are not covered to this obligation. Apart from information on those articles which contain Candidate List substances in a concentration above 0.1% w/w and administrative contact details, suppliers of articles also need to provide the following information to ECHA: information to identify of the article (including picture and characteristics); the name, concentration range and location of the SVHC(s) present in article/Product; An instruction on the safe use of the article, especially to ensure proper management of the article after it becomes waste. Dates to remember: Autumn 2019: launch of a user test group and a stakeholder workshop at ECHA (preliminary date 12 November) Early 2020: launch of the prototype version of the database July 2020: deadline for Member States to transpose the legal requirements into national law 5 January 2021: notification duty kicks in for industry ComplianceXL will help manufacturers, importers and distributers to manage their SCIP database as per ECHA. This will improve the transparency of hazardous substances, while steering clear of any problems related to certain substances and enable more accurate production capabilities.