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.
Consultations Launched for Applications for Authorization
The European Chemicals Agency (ECHA) is seeking comments on 13 applications covering 17 uses of the following: chromium trioxide (EC 215-607-8, CAS 1333-82-0): It is used to functional chrome plate, anodize aluminum spars or electroplate shock absorber rods, coat substrates with chrome, etch and electroplate substrates. In addition to its industrial applications, this chemical is also used in the hard chromium coating of complex outer surfaces of firearm auxiliary parts subject to mechanical, chemical, and thermal stress for great heat, corrosion, wear, and barrier properties, plus the ability to withstand hot combustion gas erosion after post-processing. The plating of dental instruments used by professionals for dental treatment; plating small components with simple geometries that don’t require special approval procedures for their use in demanding sectors like food, paper, and chemical production. It is an electroplating process for different kinds of substrates that are designed to produce a bright, long-lasting, durable (shiny) or matte surface (functional electroplating with decorative characteristics). 4-(1,1,3,3-tetramethylbutyl) phenol, ethoxylated (EC -, CAS-): used as a detergent in the purification of lapidated OspA protein subsequently used for manufacturing of a lyme disease vaccine candidate; 4-nonylphenol, branched and linear, ethoxylated (EC 500-209-1, CAS 68412-54-4): Mixing by the Applicant of an NPnEO-containing epoxy resin used for the manufacture of glass fibre articles for critical composite helicopter parts, that is exempt from authorization under REACH Art. 56(6)(a) More information about the uses that authorization is applied for, including the description of the function of the substance, exposure scenarios, possible alternatives identified by the applicants, together with socio-economic information, is available on the ECHA website. The deadline is 6 April 2022.
ECHA Postpones Submission Data for Bisphenol a Restriction Report
According to ECHA, the submission of the 4,4′-isopropylidenediphenol (bisphenol A, BPA) (EC 201-245-8,CAS 80-05-7) restriction report by Germany has been postponed until 7 October 2022. European Chemicals Agency (ECHA) is seeking comments on the substance and examples of its uses: N-(Hydroxymethyl)acrylamide (EC 213-103-2, CAS 924-42-5) used as monomer for polymerization.The chemical Bisphenol A (BPA) is used to make polycarbonate plastic. In addition to hard plastic items, such as baby bottles, re-usable water bottles, food containers, pitchers, tableware, and other storage containers, polycarbonate plastic is also used to make soft plastic items. BPA may have adverse effects on the fetus, infant, and child’s brain and prostate gland when exposed to it. Children’s behavior may also be affected by BPA exposure. In addition, additional research indicates that BPA may be related to increased blood pressure, type 2 diabetes, and heart disease. The deadline for comments on BPA restriction is 19 April 2022. Until the outcome of the Annex XV review and any restrictions proposed, ECHA keeps a registry of restriction intentions. A restriction proposal can be prepared by a Member State or by ECHA either on their own initiative or at the request of the Commission. An authorization request can be made for substances on the Authorization List. A Member State must inform ECHA of its intention to develop a restriction dossier as a matter of law. Interested parties can plan and prepare their comments in advance by reviewing the advance notice. Following the progress of a proposal through the restriction process is possible, starting with the notification of the intention, followed by the adoption of the final opinions by the Risk Assessment Committee (RAC), the Socioeconomic Analysis Committee (SEAC), and the adoption by the European Commission of the restriction. As part of the preparation and consultation of the restriction proposal, stakeholders are encouraged to submit any relevant information to the dossier submitters. It is important to receive information to motivate any exemptions to the scope described in the intention during the preparation phase of the dossier. Companies are responsible for making sure they are aware of the composition of the products they sell. Using ComplianceXL’s Managed Compliance Solution, you’ll enhance data collection and streamline reporting for chemical substances using regularly updated restricted substances lists.
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