Upcoming PFAS Restriction Proposal: Everything You Need to Know
In response to growing concerns about the environmental persistence and potential health risks of per- and polyfluoroalkyl substances (PFAS), the European Chemicals Agency (ECHA) is taking action within the ambit of REACH, the European Union’s regulatory framework for chemicals. PFAS, known for their unique properties like resistance to heat, water, and oil, are extensively utilized across various industries. Yet, their durability and possible adverse effects on health have prompted urgent regulatory scrutiny. Problem: The contamination caused by PFAS is linked to numerous health problems, such as cancer, immune system disturbances, and developmental issues. Due to their environmental persistence, PFAS accumulate in living organisms and extensively contaminate water, soil, and wildlife. The lack of thorough regulatory measures has enabled PFAS to permeate a wide range of consumer goods, industrial activities, and materials, thereby presenting significant threats to human health and the ecological balance. Solution: Upcoming Meetings: March 2024: Discussions on PFAS hazards in consumer mixes, cosmetics, and ski wax (reported by RAC) and the general strategy (exclusive to SEAC). June 2024: Debate on risks in metal plating and metal goods production (by RAC). September 2024: Focus on petroleum and mining, food contact materials and packaging, and textiles, furniture, leather, clothes, and carpets (TULAC). The repercussions : ECHA’s proactive approach towards evaluating and potentially restricting PFAS under REACH underscores a commitment to tackling emerging chemical risks and safeguarding human health and the environment. Collaboration among regulatory authorities, scientific committees, industry stakeholders, and the public is paramount to ensuring the effectiveness and feasibility of proposed PFAS restrictions. ComplianceXL aids businesses in achieving PFAS regulatory compliance by compiling pertinent data related to PFAS for their products. Moreover, we offer ongoing maintenance services to ensure the integrity and currency of regulatory documentation for our clients moving forward. FAQs: Q: What specific sectors are being addressed in the upcoming committee meetings? A: The sectors under discussion include consumer mixtures, cosmetics, ski wax, metal plating, metal product manufacturing, textiles, upholstery, leather, apparel, carpets, food contact materials, packaging, petroleum, and mining. Q: How will feedback from the consultation process be incorporated into the proposal? A: The five national authorities responsible for the proposal will revise and update it based on the comments received during the consultation. This updated proposal will serve as the foundation for the scientific committees’ evaluations and subsequent recommendations.
REACH SVHC Candidate List: Newly Added Substances and Their Significance
The European Chemicals Agency (ECHA) has added five new hazardous chemicals in its 30th update of the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) Candidate List, bringing the total to 240 SVHC entries. This underscores the importance of effectively managing the risks associated with these substances and underscores the commitment to enhancing chemical safety. The European Chemicals Agency (ECHA) added five new substances to the REACH SVHC Candidate List on 23rd Jan 2024. The ECHA has also updated the existing Candidate List entry for dibutyl phthalate to include its endocrine-disrupting properties for the environment. Five chemicals are added to the candidate list based on the level of their toxicity. One of them is reprotoxic, three are very persistent and very bio accumulative and one is toxic for reproduction and persistent, bio accumulative, and toxic. Newly added chemicals are commonly used in coating products, adhesives, and sealants, and washing and cleaning products. Newly added substances may be placed on the Authorisation List in the future. If a substance is part of the Authorisation list, its use will be prohibited if companies do not apply for authorization and the European Commission authorizes them to continue its use. Suppliers of articles containing an SVHC above a concentration of 0.1 % (weight by weight) must inform their customers and consumers how to use them safely and have to provide a safety data sheet. Importers and manufacturers of articles should notify ECHA if their article contains a Candidate List substance within six months from the inclusion date. Compliance XL provides consulting services to companies in the field of REACH compliance and the collection of REACH declarations. We also help customers regularly maintain their supplier certificates and declarations to ensure they are up to date as part of their compliance data management strategy. FAQs: 1.What is the REACH limit for SVHC? Article 33(1) of the REACH Regulation states that manufacturers and importers of articles (products) are required to notify their customers of the presence of any Substances of Very High Concern (SVHC) in their products exceeding 0.1% by weight and provide instructions on safe use of the product. 2.What type of chemicals are considered under REACH SVHC candidate list? Chemicals that are Carcinogenic, mutagenic or reprotoxic (CMR) category 1 or 2, persistent, bio-accumulative and toxic (PBT) substances, very persistent and very bio-accumulative (vPvB) substances, substances for which there is evidence for similar concern, such as endocrine disruptors.
Unlocking the Power of ECHA’s IUCLID Dataset with ComplianceXL
ECHA’s recent revelation of an expanded IUCLID dataset has ushered in a new era for pharmaceutical research, emphasizing a shift towards alternative testing methods. With 528 approved pharmaceuticals and a blend of animal and human trial data, this development aligns seamlessly with global aspirations for ethical and sustainable practices. This blog explores the pivotal role of ComplianceXL in enhancing the significance of the IUCLID dataset, with a focus on its contributions and impact. IUCLID (International Uniform Chemical Information Database) is a software application developed by the European Chemicals Agency (ECHA) for managing and exchanging chemical information. It helps companies comply with chemical regulations, facilitates standardized data sharing, and supports the creation of electronic dossiers containing comprehensive information about chemical substances. IUCLID plays a vital role in promoting transparency, regulatory compliance, and the development of alternatives to animal testing in the field of chemical management. Unveiled on November 7, 2023, the enriched IUCLID dataset now boasts information on 180 new substances, complementing the earlier data on 348 substances. Positioned beyond a repository of toxicological information, the dataset stands as a crucial resource for the pharmaceutical industry and the broader research community, driving progress in a more ethical direction. The primary aim of this expanded dataset is to enable a comprehensive evaluation of the toxicity of structurally similar chemicals, emphasizing a reduction in reliance on animal testing. Its versatility extends to fueling the development of predictive models, offering researchers the tools to assess similarities between animal and human data for more streamlined and ethical drug development processes. In sync with the dataset, ECHA introduces a customized ontology—a refined dictionary of toxicological terms. Tailored to standardize the classification and organization of chemical effects, this resource integrates human and mammalian ontologies with novel terms. Boasting over 20,000 new standardized terms, the ontology serves as a comprehensive guide for professionals navigating the intricate landscape of toxicology. ComplianceXL plays a pivotal role in ensuring the effectiveness and integrity of the IUCLID dataset. As a trusted compliance partner, ComplianceXL contributes expertise in regulatory compliance, data validation, and standardization, reinforcing the reliability of the dataset. The collaboration with ECHA exemplifies how ComplianceXL’ s commitment to quality and adherence to regulatory standards enhances the overall impact of this groundbreaking initiative. ECHA’s commitment to transparency is underscored by scientific papers detailing the development of the database and ontology. These papers not only unravel the intricacies of the datasets but also provide a roadmap for potential use cases. An upcoming second paper promises a deeper dive into the datasets, fortifying the foundation for future research and innovation. The IUCLID dossiers, meticulously crafted by ECHA, draw upon data extracted from documents provided by the US FDA. Covering a spectrum of studies, including carcinogenicity and reproductive toxicity, this collaborative effort underpins the credibility and comprehensiveness of the dataset, showcasing the significance of global partnerships in advancing research. ECHA’s commitment to advancing pharmaceutical research and ethical practices, coupled with ComplianceXL’s expertise, highlights the transformative power of the IUCLID dataset. Positioned as a beacon of progress, this initiative not only provides a robust foundation for toxicity assessment, predictive modeling, and standardized terminology but also exemplifies the collaborative spirit driving the future of pharmaceutical research. FAQs: 1.What is ComplianceXL’s role in the IUCLID dataset initiative? ComplianceXL serves as a compliance partner, contributing expertise in regulatory compliance, data     validation, and standardization to enhance the reliability of the IUCLID dataset. 2.How does the IUCLID dataset contribute to reducing animal testing? The IUCLID dataset facilitates a comprehensive assessment of the toxicity of structurally similar chemicals, aiming to minimize reliance on animal testing by providing valuable insights for researchers to develop predictive models.
ECHA Gears Up to Propose Restrictions on Specific Chromium VI Substances
The European Chemicals Agency (ECHA) has received a directive from the European Commission to formulate a restriction proposal under the requirements of Annex XV of the REACH Regulation, targeting at least two Chromium (VI) substances. The proposal is expected to be submitted by October 4, 2024, as specified in the Commission’s directive, accessible in full through the provided link: Link to Mandate Document Chromium (VI) substances, outlined in 11 sections (16-22 and 28-31) within the EU-REACH Authorization list (Annex XIV), are categorized as cancer-causing (1A or 1B), posing a risk to both workers and the general population when exposed to the environment. The proposed restriction will predominantly encompass the following two Cr (VI) substances: Chromium trioxide (CrO3) – Annex XIV section 16:This specific Cr (VI) substance is responsible for most applications requiring authorization. Chromic acid (H2Cr2O4) – Annex XIV entry 17: As a group of acids produced from chromium trioxide, it is imperative to include them in the scope of the restriction proposal. One of the primary applications of these substances is in electroplating, a common surface-finishing process for coating materials. Background: The European Commission has received numerous authorization applications for the use of Cr (VI) substances listed in Annex XIV, overwhelming the Risk Assessment Committee’s (RAC) capacity. This situation undermines one of the key objectives of the authorization provisions, which is the gradual replacement of such substances with economically and technically viable alternatives. Commission’s Directive: As part of the restriction proposal, the Commission has instructed ECHA to conduct a brief analysis of alternative availability and assess the potential risk of replacing other chromium (VI) substances. If deemed necessary, an expansion of the mandate is possible. The standard REACH restriction process, involving assessment by the RAC and SEAC, will follow the preparation of the proposal. ECHA will incorporate insights from processing authorization applications for these substances in the proposal’s preparation. Upon the Commission’s adoption of the restriction, the substances within the specified scope will be removed from the Authorization list, marking a significant milestone under EU-REACH. ComplianceXL, drawing on its extensive regulatory expertise, stands ready to assist companies affected by the impending restrictions on specific Chromium VI substances proposed by the European Chemicals Agency (ECHA). As ECHA prepares to submit the restriction proposal by October 4, 2024, under Annex XV of the REACH Regulation, businesses involved in the use of Chromium trioxide (CrO3) and Chromic acid (H2Cr2O4) are urged to stay informed and take proactive measures. Our compliance management services at ComplianceXL are well-equipped to support companies in efficiently navigating through the regulatory landscape associated with these proposed restrictions. We offer tailored solutions to facilitate risk assessments, compliance management, and the generation of accurate and timely reports. By leveraging over two decades of regulatory experience, ComplianceXL ensures that organizations are well-prepared to address the challenges posed by evolving regulatory requirements.
European Commission Takes Bold Steps to Combat Microplastics Pollution
On September 27, 2023, the European Commission made a noteworthy move to combat microplastic pollution. They introduced an amendment to Regulation (EC) No 1907/2006 (REACH) to restrict the intentional use of microplastics. This addition is part of Annex XVII under the EU REACH chemical legislation and focuses on synthetic polymer microparticles. Specifically, it restricts synthetic polymer particles below five millimeters in size that are organic, insoluble, and resistant to degradation. An estimated 145,000 tonnes of microplastics are used annually in Europe and the European Economic Area (EEA). Once released into the environment, microplastics pose a significant challenge as they do not easily biodegrade. They accumulate in terrestrial and aquatic ecosystems, potentially entering the food chain, including human consumption. Moreover, their presence results in persistent pollution within our ecosystems and food chains. The new regulations prohibit the sale of products containing microplastics and the sale of microplastics themselves. This affects various products, including cosmetics, detergents, fabric softeners, glitter, toys, medicine, medical devices, fertilizers, and artificial sport surface infill material. Notably, the ban on microbeads in cosmetics takes effect immediately, without a transition period. Certain products are exempt from the sales ban, including those that do not release microplastics or can minimize their release, products used at industrial sites, and products already regulated by other EU legislations. However, manufacturers of exempted products are obliged to report estimated microplastic emissions annually to the European Chemicals Agency (ECHA), along with usage and disposal instructions. Products where microplastics are unintentionally present, such as sludge or compost, fall outside the scope of these regulations. The initial measures, including the ban on loose glitter and microbeads in cosmetics, become effective on October 17, marking the entry into force of the restriction. Transition periods are provided for other affected stakeholders to allow them time to develop and switch to alternatives. ComplianceXL offers consulting services to assist companies in complying with the REACH Regulation concerning microplastics. We aid in collecting data on products containing microplastics to ensure proactive compliance with these new regulations. Our services help customers meet regulatory milestones and maintain up-to-date compliance data management practices. FAQs: 1.What is the transition period given for infill material for sport pitches? The ban applies after 8 years to give pitch owners and managers the time to switch to alternatives. 2.What are major concerns caused by Microplastics? Microplastics are not biodegradable and have been found even in food and drinking water. It contributes permanent pollution to our eco systems.
ECHA Implements New Measures to Enhance Battery Safety
Helsinki, 17 August 2023 – As part of the modernization of the EU’s battery regulatory framework, ECHA has received new projects to assist the European Commission in its operations. As part of this project, the Office will help improve a Commission report on substances of concern found in batteries or utilized in their assembly. These substances adversely affect human health, the environment, or the use of safe and high-quality raw materials for reuse/recycling. The European Commission will rely on ECHA to identify substances of concern within batteries or used in their manufacture. It will also prepare recommendations for restricting certain substances in batteries. Through this initiative, batteries on the EEA market will be more sustainable for the entire battery lifecycle. It is necessary for Europe to upgrade its batteries in order to move toward clean energy. They are also crucial to the European automobile industry. There is an expected increase of 14 folds in global interest in batteries by 2030. A revised Batteries Guideline was proposed by the European Commission in 2020 in order to limit the ecological effects of this development and to take into account changes in public opinion, new technological developments, markets, and battery purposes. The Batteries Order (Directive 2006/66/EC) was repealed by the Guideline on 17 August 2023. The law limits the use of mercury and cadmium in batteries, as well as lead in compact batteries. It also intends to: Enhance the interior market by guaranteeing a level playing field through the use of a common set of guidelines. Encourage the development of a roundabout economy. Reducing ecological and social effects throughout the battery lifecycle. ECHA’s EU assistance: It is anticipated that by 31 December 2027, the EU will recognize the substances and consider follow-up measures, such as possible EU-wide restrictions. ECHA normally begins work on this report in 2024. We have a compliance specialist who is well trained and knowledgeable about Lead and other hazardous substances, and the regulations they fall under under ECHA and EU regulations. It is also possible that the Commission will request that ECHA prepare a proposal on the limitation of destructive substances found in batteries and in waste batteries. Furthermore, the Organization will assess, through its Councils for Hazard Evaluation and Financial Examination, the viability of the limitation proposition in dealing with the gamble. It will also assess its impact on society. ComplianceXL’s services are utilized by organizations across various industry verticals for a variety of compliance-related needs, ranging from an initial compliance counselling commitment to gathering compliance statements from service providers. Since the list of providers is constantly changing, most organizations rely on our team to obtain intermittently refreshed confirmations and statements from providers in order to maintain accurate and updated compliance information. Get in touch with one of our compliance specialists today Contact Us
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!!!!
Reporting on Chemical Safety and REACH Compliance with IUCLID
The International Uniform Chemical Information Database (IUCLID) has recently updated its information requirements for registering chemicals in accordance with the REACH Regulation to ensure they comply with the regulation. As a result of the streamlined formats and absoluteness check rules included in REACH, companies can easily report their compliance with REACH requirements. This helps to reduce the cost of registration for companies, as well as the time and effort required to submit the information. Additionally, IUCLID helps ensure that the data submitted is of high quality and accuracy. There has been an update to the REACH information conditions (Additions VI to XI), which has further enhanced the safety and efficiency of chemical substances within the European Union by clarifying the information conditions. These additions also provide detailed information on the requirements for registration, evaluation, and authorization of chemicals. Furthermore, the update aims to improve the transparency of the process and ensure the safety of both people and the environment. IUCLID’s update includes the following features: Revised REACH Annexes: There has been a revision to the data formats and the rules for absoluteness checks to reflect the amended information conditions within REACH. With this release, the updated completeness checks for REACH enrolments will be applied from 1 June 2023 onwards. This change will ensure that REACH enrolments are processed more quickly and accurately. Companies must be aware of these changes and adjust their procedures accordingly. Failure to do so could result in delays or rejections of their REACH enrolments. Expanded format support: With this release of IUCLID, its format is interpreted to accommodate the Drinking Water Directive requirements. Using this format, chemical substances present in drinking water can be better evaluated. IUCLID will review and finalize the format of the document in the upcoming release of IUCLID. OECD harmonized templates (OHTs): Updates and advancements to OECD (Organisation for Economic Co-operation and Development) harmonized templates The latest release incorporates updates and advancements to the OECD (Organisation for Economic Co-operation and Development) harmonized templates. For chemical testing reports to be more accurate and standardized, these templates now consider the latest revisions to the OECD test guidelines. BPR Summary of product characteristics (SPC): In the updated version of IUCLID, a streamlined format is included for the Biocidal Products Regulation (BPR), facilitating a seamless transition from the SPC Editor to IUCLID in a smooth and efficient manner. We expect that this transition will be completed by the end of this year, resulting in a streamlined biocidal product approval process. ECHA has updated its REACH and CLP manuals to reflect these changes to help companies adapt to these changes. An updated version of the Chemical Safety Assessment and Reporting Tool (Chesar), compatible with this IUCLID release, will likely be available soon. The new Chesar version will allow companies to assess the risks of using certain substances and ensure they are compliant with the latest legislation. It will also provide detailed information about chemical properties in the EU market. This will help companies ensure their products are safe for consumers. With its team of dedicated compliance engineers, ComplianceXL assists organizations with REACH compliance documentation. Our compliance engineers stay on top of the latest changes in compliance regulations across different industries to enhance the compliance status of our clients. ComplianceXL ensures compliance with REACH obligations and avoids penalties or disruptions to organizations’ operations with its expertise and in-depth knowledge. FAQs 1.What is IUCLID? In the European Union, IUCLID supports the implementation of various chemical regulations, such as the REACH regulation. A central database for chemical data submission and exchange. Chemical substance information can be accessed and evaluated by regulatory authorities and industry stakeholders. 2.What is IUCLID’s role in supporting REACH compliance? The IUCLID provides a standardized format for companies to submit their chemical data and registrations for REACH compliance. Regulatory authorities use it for risk assessment and decision-making processes after companies collect and submit comprehensive datasets on chemical properties, uses, and hazards. It facilitates effective communication between different stakeholders by collecting information in a consistent and harmonized way.
ECHA adds two new substances to the REACH SVHC list.
The European Chemicals Agency (ECHA) has updated the Candidate List of substances of very high concern, which now includes 235 hazardous chemicals. The new chemicals have been added to the REACH SVHC Candidate List to ensure a high level of protection for the environment and the health of humans when it comes to hazardous chemicals, as part of an effort to ensure a high level of protection. It should be noted that one of the chemicals added is toxic for reproduction, whereas the other has persistent and bio accumulative properties. These chemicals are used in various products such as inks, toners, plastic production, and manufacturing processes. Organizations are responsible for managing the risks associated with these chemicals and providing information to customers and consumers about their safe use. Below are the chemicals that are added to the REACH SVHC list. S.No Substance name EC number CAS number Reason for inclusion Examples of use 1 Diphenyl (2,4,6-trimethyl benzoyl) phosphine oxide 278-355-8 75980-60-8 Toxic for reproduction (Article 57c) Inks and toners, coating products, photo-chemicals, polymers, adhesives and sealants and fillers, putties, plasters, modeling clay. 2 Bis(4-chlorophenyl) sulphone 201-247-9 80-07-9 vPvB (Article 57e) Manufacture of chemicals, plastic products, and rubber products. The addition of these hazardous chemicals to the Candidate List raises concerns about their potential negative impacts on human health and the environment. Lack of awareness about the presence and risks of these chemicals can lead to unsafe handling and use, posing risks to individuals and the ecosystem. Companies must fulfill their legal obligations under REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) regulations when their substances are included in the Candidate List. Suppliers of articles containing Candidate List substances must provide information to customers and consumers to ensure safe usage. In addition to providing a safety data sheet, suppliers of these articles above a concentration of 0.1 % (weight by weight) must inform their customers and consumers of how to safely use them. Importers, producers, and suppliers of substances on the Candidate List have specific notification and reporting requirements to ECHA to track the presence and concentration of these chemicals. If an article contains a substance on the Candidate List, importers and manufacturers must notify ECHA within six months. Notification and reporting requirements facilitate better monitoring and management of these chemicals, minimizing their negative impact on human health and the environment. ECHA’s addition of two hazardous chemicals to the Candidate List highlights the ongoing effort to identify and regulate substances that can harm people and the environment. Stricter regulations and increased transparency regarding the presence of these chemicals in products contribute to safer handling and usage. ComplianceXL helps organizations with REACH regulatory compliance services in assisting them to collect REACH information for their products. As part of our compliance data management strategy, we also assist our customers in maintaining their supplier certificates and declarations on a regular basis so that they remain up to date. Also, we will provide Maintenance services to our customers to maintain and validate the regulatory documents to make sure accurate those are up-to-date and accurate. FAQ: Q1. What is the Candidate List? A. The Candidate List is a compilation of substances of very high concern identified by the European Chemicals Agency due to their potentially harmful effects on human health or the environment. Q2. What are the benefits of the Candidate List? A. The Candidate List raises awareness about hazardous chemicals, enabling better risk management, safer product usage, and informed consumer choices. It also promotes monitoring and control of these substances, reducing their negative impact.
ECHA (European Chemicals Agency) adds 8 more substances for REACH Authorisation – 11th Recommendation kicks in.
To ensure proper control of risks for human health and the environment ECHA recommends that the European Commission adds eight substances to the REACH Authorisation List including Lead. Use of Lead in batteries, ammunition, cables, vehicles, machinery, electronics, radiation shielding, sanitary, construction, art and musical instruments comes under the scope of authorisation. As a reprotoxic substance, volume range set for lead in the scope of authorisation is >1000. The other seven recommended substances include: Ethylenediamine (CAS# 107-15-3) 2-(4-tertbutylbenzyl) propionaldehyde and its individual stereoisomers Glutaral (CAS# 111-30-8) 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one (CAS# 71868-10-5) 2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone (CAS# 119313-12-1) Diisohexyl phthalate (CAS# 71850-09-4) and Orthoboric acid of sodium salt group. Ethylenediamine and Glutaral cause respiratory ailments. Rest of recommended substances such as 2-(4-tertbutylbenzyl) propionaldehyde and its individual stereoisomers, 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one, 2-benzyl-2- dimethylamino-4’-morpholinobutyrophenone, Diisohexyl phthalate, Orthoboric acid, sodium salt are identified as toxic to reproduction. Most of these substances are part of other directives too. 2-methyl-1-(4-methylthiophenyl)-2-morpholinopropan-1-one and Diisohexyl phthalates are also part of the medical device directive, CMD (Conflict Minerals Declaration), CAD, ELV, WFD Directive. Glutaral is listed in cosmetic directive of EU (European Union) union. Once substances are added to the authorization list, companies will need to apply for authorisation for their specific uses. Also, companies should look for viable alternatives. The Candidate List of substances of very high concern has been prioritized by ECHA as the highest priority substances, following the 2014 agreement. Lead was included in the draft recommendation published on 2 February 2022, which generated a great deal of feedback during the consultation process. As a result, ECHA’s Member State Committee discussed the timing, the relationship with other ongoing or planned regulatory activities, and the expected workload for industry and authorities. To ensure worker and environmental protection, ECHA recommends the European Commission add eight substances to the REACH Authorization List, including lead. Adding substances to the list will require companies to apply for authorization to continue using them. With our clients, we make sure they are always compliant with global regulations and are always operating responsibly and sustainably. With our comprehensive solutions, organizations can assess their current compliance status and stay up to date on ECHA requirements. Additionally, we provide reporting services to ensure that all necessary documentation is completed accurately and on time. For information on the 11th recommendation of REACH Authorization, contact one of our compliance experts today.