ECHA Adds Three New Chemicals to REACH Candidate List in June 2025

On 25 June 2025, the European Chemicals Agency (ECHA) added three hazardous chemicals to its Candidate List of Substances of Very High Concern (SVHCs) under the REACH regulation. This update brings the total number of entries on the list to 250. The three new substances have been included based on their toxicity. This update aims to ensure that companies manage the risks associated with these chemicals and provide information on their safe use to customers and consumers. Newly added substances: Two of these substances are classified as very persistent and very bioaccumulative, meaning they remain in the environment for a long time and accumulate in living organisms. These are commonly used in cosmetics, personal care products, and automotive care products. The third substance is classified as toxic for reproduction, posing risks to fertility and fetal development. It is typically used in textile treatment products and dyes. Under REACH, suppliers of articles containing an SVHC in concentrations above 0.1% (weight by weight) are required to provide safety data sheets and safe use instructions to customers and consumers. Substances added to the Candidate List may eventually be included in the Authorisation List, meaning companies will need to apply for authorisation from the European Commission to continue using them. ComplianceXL provides expert knowledge and consulting services on hazardous substances added to the Candidate List. We support companies in managing compliance with EU regulations and help maintain up-to-date supplier certificates and declarations as part of a robust compliance data management strategy. FAQs: 1. What industries are most affected? Industries most impacted include cosmetics and personal care, textiles and dyes, and automotive and lubricants. 2. What should companies do after a substance is added to the Candidate List They should check for the substance in their products, update safety information, notify ECHA if needed, and prepare for possible authorisation requirements.

Upcoming PFAS Restriction Proposal: Everything You Need to Know

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.

EU project aimed at enforcing chemical regulations will focus on online products

The ECHA Enforcement Forum agreed to launch a project throughout the EU to verify that online products comply with REACH restrictions and the Classification, Labelling, and Packaging (CLP) Regulation’s requirements. The BPRS subgroup agreed to start a project on biocidal product labeling. Inspections will take place in 2025 under REACH-EN-FORCE (REF)-13. There is a high risk of noncompliance with chemical purchases made online. An earlier Forum effort (REF-8) found that online blends and objects often contained hazardous chemicals, including those that cause cancer. The investigation discovered that 78% of restricted blends or items did not meet REACH requirements. REACH regulations are intended to ensure that toys, common household items, and chemicals sold online comply with them. Inspectors will ensure that mixtures are categorized, labeled, and packaged according to CLP. Additionally, online sales provide information about mixture hazards. The POPs Regulation and RoHS Directive restrictions can also be checked by inspectors. In 2024, preparations for REF-13 and BEF-3 will begin, inspections will take place in 2025, and reports will be published in 2026. In the upcoming project, inspectors at ECHA can refer to two more stringent online sales regulations: the Digital Services Act and the General Product Safety Regulation. The Biocides on Biocidal Products Regulation of the Forum agreed that biocidal product labeling correctness will be the primary focus of the subsequent major biocide enforcement project (BEF-3). Biocides labels will be compared to what inspectors approve and include in the Summary of Product Characteristics by inspectors. Monitors may check the presence and nature of data in Security Information Sheets, where it is expected for biocidal items. A group of EU and EEA implementation experts participates in the Requirement Discussion and its BPR subgroup (BPRS). They are liable for organizing the implementation of the Scope, CLP, PIC, POPs, and the Biocidal Item Guidelines. These guidelines are determined to safeguard our well-being and the climate while ensuring a level playing field for organizations across the EU market. The BPRS met from 15 to 16 June 2023, while the Forum met from 13 to 15 June in Helsinki. November is when the next meeting will occur. In addition to our Reach compliance consulting services, we also collect REACH declarations from suppliers for clients across many industries. Due to the ever-changing SVHC list, most businesses rely on us to obtain periodic updates from suppliers for their certifications and declarations to ensure that their compliance data remains current and accurate based on the SVHC list. Find out more about our services by contacting us today!

A closer look into ECHA’s latest REACH SVHC additions

On Jan 17th, 2023, The European Chemicals Agency (ECHA) recently added nine new substances to their list of substances of very high concern (SVHC). In addition to the newly added substances, the SVHC list now totals 233 substances, up from 224 currently. REACH has added these substances to the SVHC list based on the previous public consultation, which considered persistence, bioaccumulation, and toxicity. Using these criteria, chemicals may be identified as posing significant risks to human health and the environment and therefore may require further regulation. Carcinogenic, Mutagenic or toxic to Reproduction (CMR) category 1 or 2 as per the directive 67/548/EEC Persistent, Bio accumulative and Toxic (PBT) or very Persistent and very Bio accumulative (vPvB) as per Annex XIII of REACH Any substance evaluated causing serious effects on human health or the environment The additions list includes the following nine substances: Substance Name: 4,4′-sulphonyldiphenol (bisphenol S; BPS)CAS number: 80-09-1Reason for proposal: Toxic for reproduction (Article 57c); Endocrine disrupting properties (Article 57(f) – environment); Endocrine disrupting properties (Article 57(f) – human health).Used in: Manufacture of pulp, textile, leather or fur, paper products etc. Substance Name: Perfluoro heptanoic acid and its saltsCAS number: Group compounds hence not applicableReason for proposal: Toxic for reproduction (Article 57c); PBT (Article 57d); vPvB (Article 57e); Equivalent level of concern having probable serious effects to human health (Article 57(f) – human health); Equivalent level of concern having probable serious effects to the environment (Article 57(f) – environment).Used in: stain-resistant fabrics, paper food packaging, and carpets Substance Name: MelamineCAS number: 108-78-1Reason for proposal: Equivalent level of concern having probable serious effects to human health (Article 57(f) – human health); Equivalent level of concern having probable serious effects to the environment (Article 57(f) – environment)Used in: spolymers and resins, Coating products, Adhesives and sealants, lab chemicals. Substance Name: 1,1′-[ethane-1,2-diylbisoxy]bis[2,4,6-tribromobenzene]CAS number: 37853-59-1Reason for proposal: vPvB (Article 57e)Used in: used as a flame retardant for many thermoplastic. Substance Name: 2,2′,6,6′-tetrabromo-4,4′-isopropylidenediphenolCAS number: 79-94-7Reason for proposal: Carcinogenic (Article 57a)Used in: reactive flame retardant and as an additive flame retardant in the manufacture of polymer resins, in products such as epoxy coated circuit boards, printed circuit boards and paper and textiles. Substance Name: Barium diboron tetraoxideCAS number: 13701-59-2Reason for proposal: Toxic for reproduction (Article 57c)Used in: paints and coatings. Substance Name: Bis(2-ethylhexyl) tetrabromophthalate covering any of the individual isomers and/or combinations thereofCAS number: Group of compounds hence not applicableReason for proposal: vPvB (Article 57e)Used in: flame retardant, plasticizer for flexible polyvinylchloride, wire and cable insulation, carpet backing, coated fabrics etc. Substance Name: Isobutyl 4-hydroxybenzoateCAS number: 4247-02-3Reason for proposal: Endocrine disrupting properties (Article 57(f) – human health)Used in: coating products, fillers, putties, plasters, modelling clay, inks and toners etc. Substance Name: reaction mass of 2,2,3,3,5,5,6,6-octafluoro-4-(1,1,1,2,3,3,3-heptafluoropropan-2-yl) morpholine and 2,2,3,3,5,5,6,6-octafluoro-4-(heptafluoropropyl) morpholineCAS number: Group of compounds hence not applicableReason for proposal: vPvB (Article 57e)Used in: in formulation or re-packing at industrial sites and in manufacturing etc. As a whole, the addition of these nine chemicals to the REACH SVHC list is a positive step towards improving the safety of everyday products that contain chemicals. These changes require companies to be aware of the regulations and take the necessary steps to comply. With ComplianceXL, companies can easily comply with the REACH Regulation and manage compliance documentation with ease.

ECHA recommends restriction of Bisphenols

Bisphenols are chemical compounds used for Manufacturing various plastics. They have been widely used in several consumer and industrial goods since more than six decades. Bisphenol A or BPA is the main member of this family and are commonly used as raw material in plastic and related industries including housings for electronic equipment like camera, TV bezels and many more also used as intermediates in several industries like printing. One of the key intentions of this restriction is, Bisphenols are identified as harmful to reproductive system of humans and animals. In coordination with EU Member States, ECHA has evaluated more than 100 bisphenols on their impact on human health and the environment through a variety of exposure limits. ECHA experts have listed the following advantages of group assessment over individual assessment of chemicals: It is imperative to avoid regrettable substitutions. The holistic approach saves time by using data on one substance in a group of similar substances. A Consistent regulatory action across all the substances in a group Of the 100+ Bisphenols evaluated, 34 were found to be harmful to humans and the environment, and 26 were found to be non-toxic. In addition, 22 Bisphenols are considered non-conclusive due to the lack of data, and 60 Bisphenols are not to be studied since they are either not registered or registered with less than 10 tons per year, and the remaining are still being evaluated for toxicity. Three Bisphenols have already been added to the SVHC list (Bisphenol A, Bisphenol B, and 2,2-bis(4′-hydroxyphenyl)-4-methylpentane). In October 2022, Germany will submit a proposal to restrict Bisphenols with endocrine disrupting properties, since the consultation period ended on 20th June 2022. Also ECHA has these in its restriction plan. Do you want to know detailed implications on your business and how overcome? Talk to an environmental compliance expert at ComplianceXL, today!

ECHA adds a new substance to REACH SVHC

On 10th June, 2022, The European Chemicals Agency (ECHA) has added one more substance to its list of SVHC candidates, which was updated from 223 to 224. The newly added substance to candidate list is N-(hydroxymethyl)acrylamide (CAS-924-42-5) which is mainly a carcinogen as well as Mutagen. N-(hydroxymethyl)acrylamide is generally found as intermediate compound in thermoplastic manufacturing. Also, N-(hydroxymethyl)acrylamide is classified as TOXIC LIQUID, ORGANIC, N.O.S. (N-(Hydroxymethyl)acrylamide, acrylamide, formaldehyde) with UN 2810 and dangerous for transportation by road, rail and air. As a result of substance additions to the EU REACH SVHC List, if the substances are used in products above an agreed threshold, affected companies are subject to immediate obligations. ECHA must also be informed through submissions to the SCIP Database, which include notifying customers. In addition, this obligates supply chains to contact all their immediate suppliers to identify the risks due to N-(hydroxymethyl)acrylamide. We at ComplianceXL help organizations coordinate this process from start to finish, including coverage for the SCIP Database. We do this by supplier engagement, data collection, data validation, substance calculations, and report generation as part of our EU REACH compliance documentation services. Get in touch with us today if you would like to know more about what our company can do for you regarding EU REACH compliance needs.

Compliance Alert: EU Member States to evaluate 27 substances in 2022-2024

European Chemicals Agency (ECHA) has listed 27 substances for evaluation by EU Member States under Community rolling action plan (CoRAP) for 2022-2024 under EU REACH. A total of four substances will be evaluated in 2022, while 23 substances will be evaluated in 2023 and 2024. Based on the opinions of its Member State Committee, ECHA adopted and published its CoRAP for 2022-2024 on 22 March 2022. Registrants should update the dossiers with new relevant information, such as hazards, tonnages, use, and exposure. The Community rolling action plan update covering the years 2022, 2023 and 2024 There are 27 substances listed in The Community rolling action plan (CoRAP) update for the years 2022-2024 that are suspected of posing a risk to human health or the environment and are being evaluated by 10 Member State competent authorities, under the substance evaluation process of REACH Regulation (EC) No 1907/2006 (Articles 44 to 48). There are two newly allocated substances to the plan, as well as 25 substances included in the previous CoRAP update of 2021-2023, published on 17 March 2021. There has been a postponement of the evaluation year for 20 of the 25 substances, principally to allow time for new information to be submitted. Although it is planned to evaluate four substances in 2022, 14 substances in 2023, and nine substances in 2024, there may be changes for substances listed for years 2023 and 2024 in the next CoRAP update in 2023. CoRAP withdrawn the remaining 25 substances of the 50 listed in the previous CoRAP update 2021-2023, since for six of them, the data is already deemed adequate to clarify the initial concerns, and for 19, the dossier evaluation processes require more information. If concerns remain after the completion of these processes beyond what can be clarified by dossier evaluation, the substances may be added to CoRAP again. The CoRAP update was prepared in close collaboration with the Member States, considering the criteria for selecting substances. On 1 December 2021, a draft CoRAP was submitted to the Member States and to the Member State Committee (MSC) for their opinions and published on the ECHA website on 15 December 2021. Using the MSC report, which was adopted on 21 February 2022, ECHA adopted the CoRAP update. In March 2022, the update was published on the ECHA website.

All you need to know about REACH SVHC update 2022

On January 17, 2022, ECHA added four more substances to its list of SVHC candidates, which was updated from 219 to 223. The chemicals contain hormone-disrupting properties, interfere negatively with reproductive health, are bioaccumulative, toxic, persistent, and biodegradable, which makes them harmful to humans and the environment. There are four substances listed on the Candidate List, one of which is used in cosmetics and may disrupt human hormones. In addition to these, there are two that are used in rubber, lubricants, and sealants, and which are included because they are detrimental to fertility. There is a fourth chemical that is used in lubricants and greases, and it has been added because it is persistent, bioaccumulative, and toxic (PBT), and therefore is harmful to the environment. Below are the newly added 4 chemicals in the SVHC List: tris(2-methoxyethoxy)vinylsilane: CAS number is 1067-53-4. Inclusion is due to the fact that this substance is potentially toxic for reproduction. The substance acts as a coupling agent. According to Article 57CC, the reason for inclusion is that these chemicals are toxic for reproduction. They can be found in rubber, lubricants, adhesives, inks, and fuels. (±)-1,7,7-trimethyl-3-[(4-methylphenyl)methylene]bicyclo[2.2.1]heptan-2-one covering any of the individual isomers and/or combinations thereof (4-MBC): As per Article 57 f – human health, the reason for inclusion is Endocrine Disrupting Properties. This substance is used in cosmetics. 6,6′-di-tert-butyl-2,2′-methylenedi-p-cresol: CAS number is 119-47-1. The reason for inclusion is Toxic for reproduction, as per Article 57 c. It is used in rubbers, plastics and sealants products. S-(tricyclo(5.2.1.02,6)deca-3-en-8(or 9)-yl O-(isopropyl or isobutyl or 2-ethylhexyl) O-(isopropyl or isobutyl or 2-ethylhexyl) phosphorodithioate: CAS number is 255881-94-8. As stated in Article 57d, the reason for inclusion is the persistent, bioaccumulative and toxic nature of the substance. It is commonly found in greases and lubricants. By adding these substances to the EU REACH SVHC List, the total REACH SVHC List now stands at 223 substances. Prior to this addition, SVHC 219 was added in July. Substances that are added to the EU REACH SVHC List come with immediate obligations for affected companies who use the substances in their products above the agreed threshold, which includes notifying their customers and informing ECHA through submissions to the SCIP Database. We at ComplianceXL help organizations coordinate this process from start to finish, including coverage for the SCIP Database, by performing data collection, data validation, substance calculations, and report generation as part of our EU REACH data services. Find out more about what we can do for your company in relation to EU REACH compliance by getting in touch with us today.

All you need to know about CoRAP by ECHA

CoRAP (Community Rolling Action Plan) prioritizes Substances for evaluation for a period of three years. Substances that require an immediate evaluation are listed in first year of the plan. Member states will evaluate the risk of substance listed CoRAP. ECHA updates the plan every March in order to advance planning for the coming year and add new substances. The plan can include the revision of already listed substance. When a member state has information suggesting a substance is priority for evaluation, they can notify the substance at any time for inclusion. A risk based criteria is used by ECHA and Member states for the selection of substances for the CoRAP. The selection criteria covers hazard information (Substance fall under – PBT, Endocrine disruption or CMR), exposure information and total registered volumes. CoRAP will check if the listed substance has any serious risk to Human health or environment. The evaluation might end up in either of the two ways: The risk is under control with the existing measures, need not require any additional measures. If the Member state conclude that the substance has a risk, then below options are addressed, Harmonized classification and labelling for carcinogenic, mutagenic or reproductive toxicity, respiratory sensitiser or other effects To identify as the substance of very high concern. To restrict the substance Actions outside the scope of REACH such as a proposal for EU-wide occupational exposure limits, CoRAP process uses all the dossiers registered by the registrants. As on 1st of Sep 2021, new substance evaluation conclusions are published for below 3 chemicals: Silicon Dioxide – CAS 7631-86-9. This was added to CoRAP list in 2012 and was evaluated by Netherlands. This is used as a repellent in plant protection products. Conclusions made: The substance has concluded for Harmonized Classification and Labelling, Need for follow-up regulatory action at EU level and Other EU-wide measures. Dichloromethane -CAS 75-09-2. This is added to CoRAP list in 2016 and evaluated by Italy. Dichloromethane is a restricted substance in the Annex XVII of the REACH Regulation (Entry 59). Conclusions made: This has been concluded as Need for follow-up regulatory action at EU level and Harmonized Classification and Labelling Bis(2-ethylhexyl) adipate – CAS 103-23-1. This was added to CoRAP list in 2020 and evaluated by Finland. Conclusions made: This has been concluded as Need for follow-up regulatory action at EU level and Harmonized Classification and Labelling

Did you know ECHA added 2 new substances to SVHC?

European Union (EU) added 2 additional substances to its REACH SVHC list as on 19th January 2021 and the total number of SVHCs is now 211 substances. This addition is continuation to the publication consultation conducted between September 2020 and October 2020.REACH, REACH SVHC, REACH 211, REACH Update, ECHA REACH, EU REACH Update, NEW REACH SVHC Here are the 2 Substances added to existing list of REACH SVHC. 1. Bis(2-(2-methoxyethoxy)ethyl)ether CAS number – 143-24-8 Reason – Toxic for reproduction The release of this substance to the environment is from the products such as  inks and toners, feminine hygiene products, nappies, books, magazines, machine wash liquids/detergents, automotive care products, paints and coating or adhesives, fragrances and air fresheners, welding & soldering products,  plant protection products and extraction agents. 2. Dioctyltin dilaurate, stannane, dioctyl-, bis(coco acyloxy) derivs., and any other stannane, dioctyl-, bis(fatty acyloxy) derivs. wherein C12 is the predominant carbon number of the fatty acyloxy moiety This group of substance has 3 group members. dioctyltin dilaurate; stannane, dioctyl-, bis(coco acyloxy) derivs. Stannane, dioctyl-, bis(coco acyloxy) derivs.  CAS No.: 91648-39-4 These are known to be used across a wide variety of product categories, including as stabilizers and catalysts in the production of materials such as plastics and rubber. Dioctyltin dilaurate CAS No.: 3648-18-8 This is a substance found in adhesives, sealants, coating products, paper chemicals & dyes, polymers, textile treatment products & dyes, washing & cleaning products, fillers, putties, plasters, modelling clay, pH regulators & water treatment products and leather treatment products. Reason – Toxic for reproduction The REACH Regulation puts forth obligations to organizations when these substances are included in their parts or products. As per the regulation, any product containing SVHC substances above a concentration of 0.1 % weight by weight, the organization has to provide sufficient usage information for safety, within six months of including the substance into REACH SVHC. Talk to our REACH Compliance Specialist today!

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