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.
Identification and Impact of substances of high concern
The European Chemicals Agency (ECHA) has amended the REACH Candidate List, a list of compounds of very high concern (SVHC), more than 25 times. The European Commission requests that EU member states or ECHA include substances on this list. The substance may become a very high concern substance after a detailed review and unanimous approval. The purpose of including a substance on the Candidate list is to promote, so businesses should have the tools and procedures in place to identify them quickly. It is important to choose technologies and substances that are both environmentally friendly and economically feasible. To ensure compliance and customer satisfaction, it’s crucial to control SVHC risks throughout a product’s lifecycle. It is critical for organizations to understand the fundamentals of SVHC in order to understand why monitoring them is becoming more and more important. Article 57 of the directive cites the REACH Directive as supporting the inclusion. To be included on the Candidate List, the substance must meet the following requirements: persistent, bio-accumulative, and toxic, very persistent and bio-accumulative In accordance with Annex XIII of the REACH Regulation, substances must have a half-life longer than the specified period in each matrix (ocean, freshwater or estuarine water, marine sediment, freshwater or estuarine sediment, and soil). As per the Hazardous Substances Directive, a substance must be carcinogenic, mutagenic, or toxic to reproduction, have another chronic toxicity, or be “non-observable” at concentrations under 0.01 mg/L (1 ppm). Over time, the candidate list grows, changes, and evolves. Among the biggest impacts could be the introduction of new materials and technologies that bring more sustainable solutions to the market. The first step towards effective change is to understand the REACH Candidate List and SVHC. As a result of prompt identification, less hazardous substances can be substituted for SVHCs, which facilitates compliance until alternatives are discovered. With ComplianceXL, companies maintain a solution that shows the content and hazards of their products. It identifies SVHCs quickly, alerts customers, and ensures compliance with REACH regulations. The resolute introduction of new technologies and materials demonstrating a company’s commitment to human health, the environment, and sustainability is a hallmark of corporate social responsibility and essential to the success of modern companies affected by SVHC and REACH. Get in touch with us today!!!!
Consultations on Harmonized Classification and Labelling
The European Chemicals Agency (ECHA) is seeking comments on proposed harmonized classifications and labeling for: tert-butyl 2-ethylperoxyhexanoate (EC 221-110-7, CAS 3006-82-4): This substance may damage fertility or affect the unborn child, damage aquatic life, may cause a fire if heated, and may cause an allergic reaction to the skin, according to the classification provided by companies to ECHA in REACH registrations. Products made with this substance include adhesives and sealants, coatings and fillers, putties, plasters, modeling clay, etc. This substance is also likely to be released to the environment through indoor and outdoor usage as reactive substances. Various uses of this substance are found among consumers, professional workers (widely used), industrial sites and manufacturers. There are sixteen substances in this group, which are derivatives of cyclohex-3-ene-1-carbaldehyde: It appears to be a colorless liquid. It is less dense than water and slightly soluble in water. As a result, it floats in water. Irritates skin, eyes and mucous membranes. It is used to make fabrics water resistant and to make other chemicals. Fragrances, colognes, perfumes, and personal care products use this chemical. It is also used in the manufacture of paint and coatings. biphenyl-2-ol; 2-phenylphenol; 2-hydroxybiphenyl (EC 201-993-5, CAS 90-43-7): The combined format has been used for this substance. Additional information can be found on EFSA’s consultation page as well as the Commission’s Guidelines on Active Substances and Plant Protection Products. Registrations under REACH indicate that this substance is very toxic to aquatic life, causing long lasting consequences and serious eye damage. Industrial sites and manufacturing facilities use this substance extensively in formulation and repackaging (widespread uses). Preservation films are used for the preservation of fibres, leather, rubber, and polymers, as well as construction materials. There are a variety of carpet-cleaning products available, including those that can be applied directly (or diluted) and those that can be used in mechanical carpet cleaners. Products designed to control microbial contaminants on hard surfaces or laundry. Fabric cleaning products used in washing machines. The deadline for comments is 29 April 2022. To comply with REACH regulations in the EU, you must have a detailed understanding of the manufacturing process. With ComplianceXL, organizations can actively monitor the entire supply chain in order to recognize which parts and subparts need regulatory attention and take action as applicable. ComplianceXL REACH compliance services updates automatically alongside the regulation, so manufacturers can have confidence their programs remain up to date. As part of our Managed Compliance services, we have a global team of regulatory experts who can answer questions and assist with program implementation. To learn more, call us today.
ECHA REACH Regulation: What the Regulation on Market Surveillance means to your Business?
To begin with, let us understand what market surveillance means. Market surveillance is a way to prevent and protect the securities market from any type of illegal or harmful practices. Without market surveillance, buyers are sellers would be hesitant to invest impacting the overall economic growth of the market. Market surveillance is seen in the public sector as well as in the private sector. Now that we understand the basic definition of market surveillance, we must have also started to realize the importance of regulation on market surveillance to your business. The EU market is focusing majorly on market surveillance regulation and every business has to take care of its technology and functions. Businesses must comply with the requirements that come under the legislation such as the Regulation, Evaluation, Authorization, and Restriction of Chemicals (REACH) regulation Compliance. The market surveillance regulation shall introduce new processes, tools, and training resources for better collaboration between the different groups of authorities. What does market surveillance regulation mean for your business? The market surveillance regulation sets uniform rules on conformity and market surveillance for products throughout the EU market. This is solely to ensure that the competition is reduced, and product safety is enhanced throughout the internal market. What you must understand from this is that market surveillance regulation brings changes to the global standards of eCommerce and online trading. Hence, if yours is a product-based company, then you must encourage product-related checks before exporting from the third-world nations. If you are own a business in the EU market, then you must be very careful with the product quality. Complying with the market surveillance regulation becomes a challenge when the economic operators are located in a different country than in which the products are made available. As a solution to this challenge, the market surveillance regulation clearly defines that products in the EU may only be made available in the market if there is a responsible economic player behind it. According to the REACH compliance: the term “placing on the market” has also been changed. For example, if a product available online is deemed to be placed on the market then that would be possible only if an offer is made to an end-user domiciled within an EU member state. The new market surveillance regulation will take effect on 16 July 2021. It will expedite the comprehensive cross-border powers and mutual exchange of information between the market surveillance authorities. No matter if you are a buyer or a seller, the best way to take advantage of this is to close down all the possible conformity gaps so that you can stay ahead of the non-compliant competitors before the regulation is effective. You can then take advantage of the REACH laws rather than fearing them. Various distributors, engineering services providers, fulfillment service providers are all making use of this time to form stringent business norms and controls so that they do not face any difficulties once the regulation comes into force. Here’s how you can prepare your business for the upcoming market surveillance regulation: Create a clear understanding of which market access requirement your business must meet. Develop a centralized platform to manage all product data Faster and easier reporting procedures to match the scrutiny measures of border control and market surveillance authorities. Generate faster and effective methods for documentation preparation Market surveillance regulation is important to ensure the smooth functioning of a single market by protecting consumers and workers against unsafe products. It also protects users from unfair competitors who use illegal practices. At ComplianceXL, we offer the REACH compliance consulting services that will help you prepare your business for the regulation activities. We enable businesses to understand the various market surveillance issues and create cooperation among the national and international authorities. Contact us today and use our expertise to help your business comply with market surveillance regulations.
REACH SVHC Candidate list updated
European Chemical Agency, ECHA has updated the candidate list of substance of very high concern for authorisation, in accordance with Article 59(10) of REACH regulation Annex XIV. On 25th June 2020, below 4 new chemicals added to SVHC list, making it from 205 to 209. 1-vinylimidazoleCAS: 1072-63-5Reason: Toxic for reproduction as per Article 57 (c).Found in: Production of polymers, antifoaming agents, coagulating agents, surface treatment of metals 2-methylimidazoleCAS: 693-98-1Reason: Toxic for reproduction as per Article 57 (c).Found in: Paints, varnishes, plastics as hardening promoter, manufacturing, casting and surface treatments of metals, plastic products. Dibutylbis(pentane-2,4-dionato-O,O’)tinCAS: 22673-19-4Reason: Toxic for reproduction as per Article 57 (c).Found in: As an additive and catalyst in plastic production, paints, sealants. Butyl 4-hydroxybenzoate (Butylparaben)CAS: 94-26-8Reason: Endocrine disrupting properties – human health as per Article 57(f) – human health.Found in: Cosmetics, personal care products and pharmaceuticals, flavouring agent Do you want to know, whether you company and products come under the purview of EU REACH Regulations? Talk to one of REACH Compliance Specialists today!
REACH EU and US Defense Exports – The Continuing Saga
ROHS, WEEE and REACH regulations may be European initiatives, but their influence is far-reaching. The EU is a major importer of products produced outside the European Union which come under its environmental compliance laws. These range from agricultural chemicals to FPGA designs. Here, we address the latest developments in REACH compliance as it applies to defence. REACH legislation governs the import and production of chemical substances within the EU. Certain products produced for the defence industry are exempt. However, exemption decisions were very much made on a national basis, and varied between member states. It became obvious to the EDA (European Defence Agency) that REACH compliance required a more harmonised approach. Creating a transparent, open European Defence Market aligning national exemption policies would considerably simplify matters for component manufacturers and other producers, not least those wishing to export into the European Union. In March 2010, the pMS (participating Member States) of the EDA agreed a Steering Board Decision which set common standards for REACH exemptions in the defence industry. A public web portal was also established to provide transparency over national policies and procedures. The PMS are now in the process of adopting the new international standards, which will be reviewed annually starting in 2011. In realisation of the fact that the REACH Regulation affects non-member countries of the EDA, such as the US and Canada, the Steering Board invited these “third member” states to adopt the new REACH legislation principles, further harmonising the process of supply. The Steering Board decision is a promising development in a controversial and confusing area. We at Enventure Technologies offer a number of solutions to help you cope with the complexities of ROHS, WEEE and REACH legislation.