First SVHC Update of 2025: New Substances Added to the REACH Candidate List
On January 21, 2025, the European Chemicals Agency (ECHA) expanded the Candidate List of Substances of Very High Concern (SVHCs) by adding five hazardous chemicals and updating one existing entry. With this update, the Candidate List now contains 247 entries, highlighting chemicals that pose potential risks to human health and the environment. The primary goal of this update is to ensure companies effectively manage the risks associated with these substances and provide essential safety information to customers and consumers. The newly added substances to the REACH SVHC Candidate List are: These substances have been added due to their hazardous properties. Two of them are classified as very persistent and very bioaccumulative (vPvB), while another two exhibit persistent, bioaccumulative, and toxic (PBT) characteristics. The reaction mass of triphenylthiophosphate and tertiary butylated phenyl derivatives, despite not being registered under REACH, has been identified as an SVHC to prevent regrettable substitution. Additionally, the existing entry for Tris(4-nonylphenyl, branched and linear) phosphite has been updated to indicate its endocrine-disrupting properties when it contains ≥ 0.1% w/w of 4-nonylphenol (branched and linear, 4-NP). Industry Impact : The newly added SVHCs are commonly used in lubricants, adhesives, sealants, and coatings. They also play a role in manufacturing cosmetics, personal care products, pharmaceuticals, electrical and electronic equipment, optical devices, machinery, and vehicles. Effects and Compliance Requirements The inclusion of these substances in the Candidate List encourages companies to seek safer alternatives. Under REACH regulations: Compliance XL offers expert consulting and training services to assist businesses in achieving REACH compliance. Our team supports companies in collecting and managing REACH declarations, ensuring that supplier certificates remain up to date and compliant with regulatory requirements. FAQs: 1. What is the one updated entry in the REACH Candidate List? The entry for Tris(4-nonylphenyl, branched and linear) phosphite has been revised to reflect its classification as an endocrine disruptor, particularly when it contains ≥ 0.1% w/w of 4-nonylphenol (branched and linear, 4-NP). 2. Which newly added SVHC has no active registrations but is still included in the list? The reaction mass of triphenylthiophosphate and tertiary butylated phenyl derivatives has been added despite having no active REACH registrations, as a precautionary measure to prevent regrettable substitution.
ECHA proposes to add 9 new chemicals as SVHC
Change is in the air again with ECHA proposing to add nine more substances to SVHC, if approved the number of SVHC will increase from 224 to 233. The European Chemicals Agency (ECHA) launched the public consultation for the 28th update of the REACH Candidate List on 2 September 2022. The public consultation will end on 17 October 2022. Based on the previous public consultation, the following criteria are used to identify and propose SVHCs: Carcenogenic, Mutagenic or toxic to Reproduction (CMR) category 1 or 2 as per the directive Directive 67/548/EEC Persistent, Bioaccumulative and Toxic (PBT) or very Persistent and very Bioaccumulative (vPvB) as per Annex XIII of REACH Any substance evaluated causing serious effects to human health or environment Below are the substance details and its applications: 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: Perfluoroheptanoic 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: polymers 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. Timelines: The deadline for comments from all affected/concerned parties is 17 October 2022. Interested in learning more about the upcoming REACH update and its impact on various industries? Talk to one of our compliance specialists at ComplianceXL.
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.
All you need to know about PFCAs restricted by EU under Annex 17
PFCAs (perfluorocarboxylic acids), a subset of PFAs (per- and polyfluoroalkyl substances) has been restricted by European commission – under Annex XVII of REACH Regulation. This new regulation replaces the entry 68 of Annex 17 to REACH on PFOA. PFOA related substances are now regulated under POPs regulation (EU) 2019/1021. It restricts the PFCAs and their salts, containing 9 to 14 carbon atoms in the chain (C9-C14 PFCAs). The below substances are excluded from the definition: CnF2n+1-C (= O) OX’ where n> 13 and X’=any group, including salts CnF2n+1-X, where X = F, Cl, or Br where n = 9, 10, 11, 12, 13 or 14, including any combinations thereof. Companies cannot manufacture, use or place the PFCAs and their salts on the market from 25th Feb 2023. These are toxic and very persistent and very bioaccumulative (vPvB). C9-C14 PFCAs act as a substitute for PFOA. This is also added under Candidate List as substances of very high concern (SVHCs) under REACH. It can be used as a constituent in other substances, mixtures or articles, if the mixture, or the article is below 25 ppb for the sum of C9-C14 PFCAs and their salts or 260 ppb for the sum of C9-C14 PFCA-related substances. The regulation is applicable from 4th July 2023 to: Textiles for oil – and water repellency for protection of workers from dangerous liquids. The manufacturer of polytetrafluoroethylene (PTFE) and polyvinylidene fluoride (PVDF), used in the production of: Industrial sealants capable of preventing volatile organic compound leakage. Equipment for industrial waste heat exchange. Membranes used in corrosion resistant gas filters, water filters and medical devices. The regulation is applicable from 4th July 2025 for: Photographic coatings applied to films. Implantable and invasive medical devices. Fire-fighting foam for liquid fuel vapor suppression and liquid fuel fire for Class B fires. photolithography or etch processes used in the manufacture of semiconductors. Different transition periods are granted to certain industry and professional. Articles placed before 25th of Feb 2023 on EU market are exempted. Talk to one of our REACH Regulation Specialists today!
2 Potential SVHCs for REACH Candidate list, June 2015
The 13th version of the REACH Candidate List (CL) is expected to be published in June 2015 with more additions. Since suppliers or product manufacturers are continuously monitoring the CL to keep their product in compliance with REACH, it’s always good to know the Substances of Very High Concern (SVHCs) earlier to start the proceedings. Only two substances have been proposed for inclusion as SVHCs this time by the member states.