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.
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 proposed 7 substances for Authorization
On 14th April 2021, ECHA recommended to add below 7 substances under authorization to protect people and environment. These includes cyclosiloxanes D4, D5 and D6. These are hazardous, produced in high volumes and widely used. If these products get added into Authorization list, companies need to apply for authorization for further using them. Octamethylcyclotetrasiloxane (D4) – used in washing and cleaning products, polishes, waxes, manufacture of silicones such as sealants which is widely used in the industry. Decamethylcyclopentasiloxane (D5) – used in washing and cleaning products, polishes, waxes, dye additive, textile treatments and manufacture of silicones such as sealants. Dodecamethylcyclohexasiloxane (D6) -– used in washing and cleaning products, polishes, waxes, manufacture of silicones such as sealants which is widely used in the industry. Terphenyl, hydrogenated -used as additives in tapes, electrical insulation coatings compounds, epoxy resins, polyurethane, electric cables, polysulphide sealants, heat transfer fluid, as a plasticiser in high voltage power cables and aircraft sealants. Dicyclohexyl phthalate (DCHP) – used as a plasticiser in polymers like PVC, additives in resins, paints and varnishes and also in water resistance in inks. Disodium octaborate -used in paints, lubricants, adhesive and construction material. Benzene-1,2,4-tricarboxylic acid 1,2-anhydride (trimellitic anhydride, TMA) – this does not have any used under authorization scope. But, included to avoid substitution in epoxy resin hardeners. Directly or indirectly, you will be affected by this authorization, talk to one of experts to understand how you can simply REACH Compliance management. Read more about the ECHA Proposal here
REACH AUTHORIZATION LIST – 18 NEW SUBSTANCES
On 1ST Oct ,2019, European Commission recommended 18 substances of very high concern for (SVHC) to be added in REACH authorization list. These substances are reproductive toxicants, endocrine disruptors, carcinogens, very persistent and very bio accumulative (vPvB) substances or respiratory sensitizers. They are prioritized due to their high volume and widespread use that can be a threat to human or environment. The European Commission in collaboration with the Member States and the European Parliament, will take final decision on the inclusion of the substances in the Authorization List and on the dates by which companies will need to apply for authorization to ECHA. List of 18 substances included in the ninth recommendation: 4,4′-isopropylidenediphenol (Bisphenol A; BPA) – Toxic for reproduction, Endocrine disrupting properties in human health and environment. It’s found in Epoxy resin hardeners. 1,6,7,8,9,14,15,16,17,17,18,18- Dodecachloropentacyclo[12.2.1.16,9.02,13.05,10]octadeca7,15-diene (“Dechlorane Plus”™) has got vPvB properties .It’s a Flame retardant in adhesives and polymers. Reaction products of 1,3,4-thiadiazolidine-2,5-dithione, formaldehyde and 4-heptylphenol, branched and linear (RP-HP) with ≥0.1% w/w 4-heptylphenol, branched and linear (4-Hbl) has Endocrine disrupting properties. Affects environment. Used in Lubricants and greases. 2-ethylhexyl 10-ethyl-4,4-dioctyl-7-oxo-8-oxa-3,5- dithia-4-stannatetradecanoate (DOTE) is toxic for reproduction. Found as stabilizer in polymers. Reaction mass of 2-ethylhexyl 10-ethyl-4,4-dioctyl-7- oxo-8-oxa-3,5-dithia-4-stannatetradecanoate and 2- ethylhexyl 10-ethyl-4-[[2-[(2-ethylhexyl)oxy]-2- oxoethyl]thio]-4-octyl-7-oxo-8-oxa-3,5-dithia-4- stannatetradecanoate (reaction mass of DOTE and MOTE) – is toxic for reproduction. Found as stabilizer in polymers. 4,4′-bis(dimethylamino)-4”-(methylamino)trityl alcohol with ≥ 0.1% of Michler’s ketone (EC No. 202-027-5) or Michler’s base (EC No. 202-959-2) has carcinogenic properties. Available in printing inks. Dioxobis(stearato) trilead is toxic for reproduction. Used as stabilizer in PVC. Fatty acids, C16-18, lead salts are toxic for reproduction. Used as stabilizer in PVC. Trilead dioxide phosphonate is toxic for reproduction. Used as stabilizer in PVC.; rubber production; mirror backing. Sulfurous acid, lead salt, dibasic has reproductive toxicity. The substance has no registered uses but is recommended based on grouping considerations as it could potentially replace other lead stabilizers in some of their uses. This is to avoid regrettable substitution. [Phthalato(2-)]dioxotrilead has reproductive toxicity. The substance has no registered uses but is recommended based on grouping considerations as it could potentially replace other lead stabilizers in some of their uses. This is to avoid regrettable substitution. Trilead bis(carbonate) dihydroxide is Toxic for reproduction. Found in Artists’ paints. Lead oxide sulfate is Toxic for reproduction. Used in Mirror backing. Cyclohexane-1,2-dicarboxylic anhydride [1], cis-cyclohexane-1,2-dicarboxylic anhydride [2], trans-cyclohexane-1,2-dicarboxylic anhydride [3] (HHPA) has respiratory sensitising properties. Found in epoxy resin hardeners. Hexahydromethylphthalic anhydride [1], Hexahydro-4-methylphthalic anhydride [2], Hexahydro-1-methylphthalic anhydride [3], Hexahydro-3-methylphthalic anhydride [4] (MHHPA) has respiratory sensitising properties. Found in epoxy resin hardeners. Tetraethyllead is Toxic for reproduction. Found as an additive in aviation fuel. 2-methoxyethanol is Toxic for reproduction. Used as a solvent. 2-ethoxyethanol is Toxic for reproduction. Used as a solvent. Once the final dates are out, the selected companies will compulsorily need to apply for Authorization to ECHA. The inclusion of these substances will avoid any further damage and the substances then will be safe to use. Talk to our REACH Compliance Experts – +1 872 529 6162 or Email us at [email protected].
Reach SVHC List updated-Four new substances added
On 16th July, the European Chemical Agency (ECHA) has updated REACH SVHC list by adding 4 new substances having properties given below. Toxicity to reproduction Endocrine disruption Very Persistent and Very Bioaccumulative (vPvB) substances Persistent, Bioaccumulative and Toxic (PBT) The decision to include the substances Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) and 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy) propionic acid, its salts and its acyl halides was taken with the involvement of the Member State Committee (MSC). The new substances included in the Candidate List are: 2-methoxyethyl acetate Tris(4-nonylphenyl, branched and linear) phosphite (TNPP) with ≥ 0.1% w/w of 4-nonylphenol, branched and linear (4-NP) 2,3,3,3-tetrafluoro-2-(heptafluoropropoxy)propionic acid, its salts and its acyl halides (covering any of their individual isomers and combinations thereof) 4-tert-butylphenol The last substance on the list that is 4-tert-butylphenol has been added to the list after it was identified as an SVHC by the EUROPEAN commission due to the endocrine disrupting properties it holds. The substances mentioned above are usually used as antioxidants to stabilize polymers, in coating products, polymers, adhesives, as a processing aid in the production of fluorinated polymers and for synthesis of other substances. It is mandatory for any organization dealing with these products in the European Union to communicate the presence of SVHCs in their products above the concentration of 0.1% (weight by weight) within six months of date of substance inclusion in the candidate list by ECHA, for which the latest update is 16th July, 2019. To avoid business continuity risks and to stay compliant, it is best to keep an active check on ECHAs SVHC list. This addition made an increase in total SVHC from 197 to 201. For more information on these obligations, talk to our REACH compliance expert – Call +1 872 529 6162
Reach SVHC List updated – 6 new substances added
On the 15 January 2019, the European Chemicals Agency (ECHA) announced six new additions to the REACH candidate list of Substances of Very High Concern (SVHCs) having below properties Carcinogenic, toxic to reproduction, Persistent, bio-accumulative and toxic (PBT) Very persistent and very bio accumulative (vPvB) Endocrine-disrupting The inclusion of Polycyclic Aromatic Hydrocarbons (PAHs) was considered with the involvement of the Member State Committee (MSC). The PAH cases were referred to MSC based on submissions received during the REACH public consultation. With this addition, the total number of SVHCs under ECHA is increased to 197 from 191 substances. The new substances included in the Candidate List are: 2,2-bis(4′-hydroxyphenyl)-4-methylpentane (CAS no. 6807-17-6) Benzo[k]fluoranthene (CAS no. 207-08-9) Fluoranthene (CAS no. 206-44-0) Phenanthrene (CAS no. 85-01-8) Pyrene (CAS no. 129-00-0) 1,7,7-trimethyl-3-(phenylmethylene)bicyclo[2.2.1]heptan-2-one (CAS no. 15087-24-8) These substances are found in a variety of products from electronic and electrical appliances, toys, paints, chemicals and plastics. The companies are required to verify and identify if such substances are present in both semi-finished and finished products. Any organisation involved in the manufacture or sales of products in the European Union (EU) will need to communicate the presence of SVHCs in their products above the concentration of 0.1% (weight by weight), within six months from the date of substance inclusion in the candidate list by ECHA, which for the latest update is January 15,2019. All manufacturers/suppliers need to keep an active check on this SVHC list to stay compliant and avoid business continuity risks. If the manufacturer’s articles or products contain any substance included in the SVHC list above accepted concentration level, they need to fulfil the following obligations: REACH article 33 : Communication of information on SVHCs to the entire supply chain REACH article 7(2) : Notification of SVHCs to ECHA Learn more about compliance best practices? Connect with our compliance specialists at [email protected].