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.
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.
24 substances under evaluation for REACH
The Community Rolling Action Plan (CoRAP) is a tool used by the European Union (EU) to prioritize the risk assessment of substances that are already on the market and are not yet fully registered under REACH. The CoRAP is updated annually and includes a list of substances that will be evaluated by ECHA in the coming year. It is designed to ensure that the most hazardous substances are identified and prioritized for risk assessment and risk management measures. The draft is for an annual update of the CoRAP and covers the three subsequent years 2023-2025. It contains substances suspected of posing a risk to human health or the environment. Substance evaluation is the process under REACH Regulation (EC) No 1907/2006 (Articles 44 to 48) that allows generation of information for clarification of such potential risks. The draft CoRAP contains 24 substances, including 6 new substances compared to the current CoRAP 2022-2024; 5 substances are being planned for evaluation in 2023, and 19 are divided for evaluation in 2024 and 2025. Five substances are proposed to be withdrawn from the 27 substances included in the CoRAP update published on 22 March 2022. This is because substance evaluation has been deemed low priority or unnecessary. For 3 out of these, the data obtained from compliance check or public literature are already considered sufficient to clarify the initial concerns, while for the remaining 2, relevant information is requested under dossier evaluation processes. These substances may be put on CoRAP again, if after the conclusion of these processes, concerns would remain beyond what can be clarified through dossier evaluation. In the draft CoRAP are the names of the non-confidential substances, the EC/List numbers, CAS numbers, and the initial grounds for concern. It also includes contact information for the Member State that intends to conduct the substance evaluation. As part of the preparation of the draft, the criteria for selecting substances were closely discussed with the Member States. The draft plan has been submitted on 30 November 2022 to the Member State Competent Authorities and the ECHA Member State Committee. It is expected that the Committee will give its opinion on this draft CoRAP update in February 2023. In accordance with the Committee’s opinion, ECHA intends to adopt and publish the CoRAP update for 2023-2025 on 21 March 2023. Each substance in the CoRAP will be accompanied by a justification document. ECHA publishes this draft now in order to provide stakeholders with a status report. It also aims to facilitate early communication between the concerned registrants and the responsible Member State authority.
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.
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.
ECHA Updated the SVHC list for REACH Regulation
On July 8th 2021, ECHA updated the REACH SVHC to 219, by adding 8 hazardous substances into the current 211 SVHC list. ECHA published updates EU REACH SVHC Candidate List twice a year by European Chemicals Agency (ECHA). In this new update, ECHA has included substances used in cosmetics, scented products, rubber, textiles, and some of them are used as solvents, flame retardants or to manufacture plastics products. These substances listed as SVHC are hazardous to human health and are toxic for reproduction, carcinogenic, respiratory sensitizers, or endocrine disruptors. Organizations are entitled to follow legal obligations and have to notify ECHA under REACH Regulation about the usage of these substances in their products. Here is the list of newly added 8 chemicals: 2-(4-tert-butylbenzyl)propionaldehyde and its individual stereoisomers : Added to the list because, its toxic to reproduction. Used in Polishes, cleaning agent, scented products, and cosmetics Orthoboric acid, sodium salt (CAS -13840-56-7): Added to the list because, its toxic to reproduction and can be found as a solvent in corrosion and inhibitor. 2,2-bis(bromomethyl)propane-1,3-diol (BMP); 2,2-dimethylpropan-1-ol, tribromo derivative/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA); 2,3-dibromo-1-propanol (2,3-DBPA): Added to the list because it is carcinogenic. 2,2-bis(bromomethyl)propane1,3-diol (BMP) (CAS – 3296-90-0)- seen while manufacturing of polymer resin and in component 2,2-dimethylpropan-1-ol, tribromo derivative (CAS – 36483-57-5)/3-bromo-2,2-bis(bromomethyl)-1-propanol (TBNPA) (CAS- 1522-92-5) -Used in polymer production manufacture of plastics products. 2,3-dibromo-1-propanol (2,3-DBPA) (CAAS -96-13-9) – Now registered as an intermediate. Glutaral (CAS -111-30-8): Added due to Respiratory sensitizing properties. Used in cosmetics, biocides, leather tanning, and x-ray film processing. Medium-chain chlorinated paraffins (MCCP) UVCB substances consisting of more than or equal to 80% linear chloroalkanes with carbon chain lengths within the range from C14 to C17 – Added due to PBT. Used Flame retardants, plasticizing additives in plastics, sealants, rubber, and textiles. Phenol, alkylation products (mainly in para position) with C12-rich branched alkyl chains from oligomerization, covering any individual isomers and/ or combinations thereof (PDDP) – Added due to reproduction toxicity, Endocrine disrupting properties. Used in the preparation of lubricant additive materials and of fuel system cleaners. 1,4-dioxane (CAS 123-91-1) – Added due to carcinogenic. Used in solvents. 4,4′-(1-methylpropylidene)bisphenol (CAS 77-40-7) – May be used in manufacture of phenolic and polycarbonate resin. Talk to one of our REACH Compliance Specialists today to learn how this update will affect you and what you need to do in order to comply with the REACH Regulation!
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!