3; STOT RE 1. Ethylene oxide can cause bodily harm if you inhale the vapor, if it comes into contact with your eyes or skin, or if you swallow it. 263. This list contains a non-exhaustive list of Carcinogens, Mutagens and Reproductive substances (CMRs) that are not allowed for use in components of active and intelligent materials and articles per Art. The non-exhaustive list is based on: (1) the flammable content, and (2) flammable aerosol definitions in sections 1.8 and 1.9, and (3) the labelling requirements given in section 2.2, of the Annex to the Aerosol Dispensers Directive 75/324/EEC. Data is excluded from dossiers where the tonnage is claimed confidential, from Intermediate registration dossiers, and from NONs which have not been updated. This list contains substances which are banned from use in any cosmetic products marketed for sale or use in the European Union. This list contains the ADR Dangerous Goods List, as implemented by the European Union's Directive 2008/68/EC. The REACH Registered substance portal was updated on 9th November 2020; the REACH registered factsheets were further updated on 21st December 2020. 3(8), and Annexes I and III. Total tonnage band – calculated per factsheet from all contributing registrations, based on the estimated quantity of the substance placed on the market. This list contains the Union list of authorised monomers, other starting substances, macromolecules obtained from microbial fermentation, additives and polymer production aids. 1910.1047 (e) (2) Access to regulated areas shall be limited to authorized persons. 1B; Acute Tox. The ‘Substance has nanoform’ search filter returns all factsheets containing any data related to nanomaterials. E0. It is also used as a fumigant in certain agricultural products and as a sterilant for medical equipment and supplies. Gas 1; Carc. This substance is registered under the REACH Regulation and is manufactured in and / or imported to the European Economic Area, at ≥ 1 000 000 tonnes per annum. PxBH(M) TU38 TE22 TE25 TA4 TT9 TM6. 2TF. Registration type – indicating whether a given factsheet contains data from a REACH full registration, REACH intermediate registration, or only a limited set of data inherited from a NONS notification. The use of ethylene oxide as a component of plant protection products is prohibited under EU regulation but its use as part of biocidal products is authorized for certain items. EPA is currently reviewing Clean Air Act regulations for facilities that emit ethylene oxide including commercial sterilizers and miscellaneous organic chemical manufacturing facilities. HP3 Flammable Waste (FW): (a)liq FW with flash pt <60°C or FW gas, diesel and light heating oils with flash pt >55°C and ≤75°C (b)pyrophoric liq/solid FW liable to ignite within 5 min after air contact (c)solid FW readily combustible or which may cause/contribute to fire by friction (d)gas FW which is F in air at 20°C and 101.3 kPa (e)water reactive FW which, in contact with water, emits F gases in dangerous quantities (f)other: aerosols, self-heating, organic peroxides and self-reactive FWs. 1 Not permitted to be carried in limited quantities, ETHYLENE OXIDE WITH NITROGEN up to a total pressure of 1 MPa (10 bar) at 50 °C, Beans (Species listed with code numbers 0260010-xxx, dried seeds, except soyabeans/edamame), Baby leaf crops (including brassica species), Leaf vegetables, herbs and edible flowers, Teas, Coffee, Herbal Infusions, Cocoa and Carobs, Brassica vegetables (excluding brassica roots and brassica baby leaf crops), Products of animal origin - Terrestrial animals, Flam. It has been determined to be carcinogenic to humans. Regulations/ Guidelines for Ethylene Oxide Exposure limits and guidelines when using ethylene oxide have been set by a number of national agencies including the following: OSHA : Occupational and Safety Health Administration OSHA Permissible Exposure Limit (PEL) : 1.0 ppm (8 Hr TWA) -Duties: Employers have a duty to provide a safe work environment and employees have a duty to work safely. Previous consultations on ECHA’s Executive Director Requests to the Committees, Applications for authorisation consultations, Harmonised classification and labelling consultations, ECHA Executive Director’s requests related to the CLH process, Consultation on potential candidates for substitution, Consultation on derogation to the exclusion criteria, ECHA's Executive Director Requests to the Committees, Consultation on a draft recommendation for amendment of Authorisation List entries, Consultations in the authorisation process, Occupational exposure limits - Call for comments and evidence, Occupational exposure limits - Previous calls for comments and evidence, Occupational exposure limits – Consultations on OEL recommendation, Derogations for the protection of cultural heritage, ECHA's current activities on restrictions, ECHA's completed activities on restriction, Information on Candidate List substances in articles table, Information from the Existing Substances Regulation (ESR), PBT/vPvB assessments under the previous EU chemicals legislation, Adopted opinions and previous consultations on applications for authorisation, Adopted opinions on restriction proposals, Mapping exercise – Plastic additives initiative, Occupational exposure limits substance evaluations, List of substances subject to POPs Regulation, Small and Medium-sized Enterprises (SMEs), Practical examples of chemical safety reports. REACH regulation aims to improve the protection of human health and the environment from the risks that can be posed by chemicals. Close Find out more on how we use cookies. What is the Classification and Labelling Inventory? Any potential association between ethylene oxide and cancer is linked only to chronic exposure. Employers are obligated to minimize worker exposure to these agents as far as possible, and must arrange for medical surveillance of workers exposed to these substances. It is based on the relevant subset of substances with harmonised classification listed in Table 3 of Annex VI to the CLP Regulation 1272/2008/EC. Ethylene oxide (EtO) is produced in large volumes and is primarily used as an intermediate in the production of several industrial chemicals, the most notable of which is ethylene glycol. Ethylene oxide is a flammable, colorless gas used to make other chemicals that are used in making a range of products, including antifreeze, textiles, plastics, detergents and adhesives. This list contains the maximum residue level (MRLs) entries as listed in the following annexes of Regulation (EC) No 396/2005 on maximum residue levels of pesticides in or on food and feed of plant and animal origin and amending Council Directive 91/414/EEC: (1) Annex II: Maximum Residue Levels; (2) Annex III: Temporary MRLs; (3) Annex IV: Active Substances for Which No MRLs Are Required; and (4) Annex VII: Active Substance/Product Combinations. This list contains a non-exhaustive inventory of hazardous substances as defined by Article 2(11) of the End-of-Life Vehicles Directive 2000/53/EC. 1B; Repr. Pursuant to Art. The same limit has been This list contains: (1) the hazardous substances with harmonised classifications and labelling (i.e., Table 3 of Annex VI to CLP Regulation); and (2) the Candidate List of substances of very high concern (SVHC). In addition, the This list contains hazardous substances in accordance with the Medical Devices Directive's (MDD) design and construction requirements pursuant to Annex I, Part II (7) & (8) (i.e., chemical, physical and biological properties; and infection and microbial contamination). 1B Category 1B, presumed to have carcinogenic potential for humans, classification is largely based on animal evidence. EPA regulates EtO under the Clean Air Act. ETHYLENE OXIDE WITH NITROGEN up to a total pressure of 1 MPa (10 bar) at 50 °C. Ethylene oxide is one of 187 hazardous air pollutants or “air toxics” that EPA regulates under the Clean Air Act. In the EU Regulation in force the ethylene oxide residue is defined as Ethylene oxide (sum of ethylene oxide and 2-chloro-ethanol expressed as ethylene oxide). It covers their hazardous properties, classification and labelling, and information on how to use them safely. Dive Brief: New draft regulations on ethylene oxide do not appear imminent after an Environmental Protection Agency announcement it will not issue a proposed rule on commercial sterilizers immediately, instead opting to issue an Advance Notice of Proposed Rulemaking and request for information in October. Please upgrade your Internet Explorer to a newer version. ; Separately, it is unclear how long it will be until a second proposed rule that … Ethylene oxide | C2H4O | CID 6354 - structure, chemical names, physical and chemical properties, classification, patents, literature, biological activities, safety/hazards/toxicity information, … The current EPA regulation for sterilization facilities, issued in 1994, requires sterilization plants to use devices that reduce ethylene oxide in exhaust gases by 99%. Therefore, It is clear that, to comply with this definition, it’s necessary to use a method that co-determine ethylene oxyde and 2-chloro-ethanol. V10 Verification of compliance by residual content per food contact surface area (QMA) in case of reaction with food or simulant. 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