REACH Regulation stipulates that manufacturers and importers of chemicals and other tangible products entering the EU market have the following obligations:
(i) Registration
(Collate and submit a detailed report including test data for each chemical substance contained in the product.) The scope of registration of chemical substances under REACH Regulation mainly includes:
1. Substances in stand-alone substances or preparations in quantities of ≥1 ton/year/person;
2. Substances in the form of monomericunits or compounds ( chemically bound substances) in polymers;
3. Substances in articles in a total amount of >1 ton/year/person that are intentionally released under normal or reasonably foreseeable conditions of use;
4. Substances in articles in a total amount of >1 ton /year/person, the Chemicals Bureau may require registration of substances in articles that the Chemicals Bureau has reason to suspect will be released from articles and that such release will be harmful to human beings or the environment.
REACH regulations, exempted from registration of substances:
1. 1 tons / year / person of substances
2. radioactive substances
3. Customs under the supervision of not to do any treatment or processing: (1) for re-export to the temporary storage, or bonded zone or bonded warehouse; or (2) in transit
4. non-separated intermediates
5. transport of intermediates
5. p>
5. Means of transport for the transportation of hazardous substances
6. Waste
7. Exemptions granted by Member States for reasons of national defense
8. Pharmaceuticals or veterinary medicines
9. Additives to food or feed, food flavorings and animal nutrients
10. Substances contained in Annex IV (known to be of very low risk)
11. 11. Substances in Annex V
12. Re-importation of registered substances by themselves or in products
13. Substances in registered substances by themselves, in products, or in articles in the event of reprocessing (recovery process)
14. Polymers (polymers by themselves) (but with unregistered content [w/w] ≥ 2% and total amount ≥ 1 ton in an upstream supplier) 2% and total amount ≥ 1 ton/year, except for monomers or other substances existing in polymers in the form of monomericunits or chemically bound substances)
15. Chemical substances used only in products or research and development (PPORD) (5+5/10 years)
16. Active ingredients and excipients (co-formulants) used only in plant protection products (deemed to be registered)
17. Active ingredients used only in biocides (deemed to be registered)
18. Substances for which a declaration of a new chemical substance has been made in accordance with the Directive 79/831/EEC (deemed to be registered) List of the First Batch of Substances of Very High Concern (SVHC I) SVHC I No. Substance EC No. CAS No. 1 Anthracene Anthracene 204-371-1 120-12-7 2 4,4'-Diaminodiphenylmethane
(4,4'Diaminodiphenylmethane) 202-974-4 101-77-9 3 Dibutyl phthalate (Dibutyl phthalate) 202-974-4 101-77-9 3 Dibutyl phthalate (Dibutyl phthalate) 202-974-4 101-77-9 Dibutyl phthalate (Dibutyl phthalate) 201-557-4 84-74-2 4 Cobalt dichloride (Cobalt chloride) 231-589-4 7646-79-9 5 Diarsenic pentaoxide (Diarsenic pentaoxide) 215-116-9 1303-28-2 6 Diarsenic trioxide (Diarsenic trioxide) 215-116-9 1303-28-2 6 Diarsenic trioxide (Diarsenic trioxide) 215-116-9 1303-28-2 diarsenic trioxide) 215-481-4 1327-53-3 7 Sodium dichromate dihydrate (combined) 234-190-3 7789-12-0 10588-01-9 8 Musk xylene
(5-tert-butyl-2,4,6- trinitro- m-xylene(musk xylene)) 201-329-4 81-15-2 9 Bis(2- ethyl hexylphthalateDEHP) 204-211-0 117-81-7 10 Hexabromocyclododecane and its diastereoisomers
(Hexabromocyclododecane and its diastereoisomers
(Hexabromocyclododecane and its diastereoisomers
(Hexabromocyclododecane and its diastereoisomers
) p>(Hexabromocyclododecane (HBCDD) andall major diastereoisomers identified
(α-HBCDD, β-HBCDD, γ- HBCDD)) 247-148-4
and
221-695-9 25637-99-4 and 3194-55-6
(134237-51-7, 134237-50-6, 134237-52-8) 11 C10-13 short-chained chlorinated paraffins
(Alkanes,C10-13, chloro(Short Chain), chloro(Short Chain), chloro(Short Chain), chloro(Short Chain), chloro(Short Chain), chloro(Short Chain))). chloro(Short Chain
Chlorinated Paraffins)) 287-476-5 85535-84-8 12 Tributyltin oxide Bis tributyltin) oxide) 200-268-0 56-35-9 13 Lead hydrogen arsenate Arsenate) 232-064-2 7784-40-9 14 Butyl phthalate Benzyl butyl phthalate 201-622-7 85-68-7 15 Triethyl arsenate Triethyl
arsenate) 427-700-2 15606-95-8 Second batch of substances of very high concern Substance List SVHC II
The European Chemicals Agency (ECHA) yesterday formally added 14 substances to the list of Substances of Very High Concern (SVHC), which will be required to fulfill the obligation of supply chain information transfer in REACH, and the downstream product suppliers must provide the content of these substances in their products free of charge, either in written form or electronically, within 45 days of the customer's request. Specific information. Reo Technology reminds manufacturers or importers of these substances that they must check their possible obligations under this list, not only with regard to the substances themselves, but also with regard to mixtures and articles containing these substances. The substances on this list include five forms of polyaromatic-anthracene, high-temperature coal pitch, 2,4-dinitrotoluene, lead chromium molybdenum red sulfate, lead yellow thiochromate, tris(2-chloroethyl) phosphate, alumina silicate refractory ceramic fibers, zirconia alumina silicate refractory fibers, and lead chromate*** 14 kinds of substances, removing acrylamide from the list of the 15 substances of high concern that were adopted by the member state committees of the ECHA in December of last year. Although the ECHA member state committees identified acrylamide as a substance of high concern, the President of the Court of First Instance of the European Union canceled the inclusion of the substance in the list this time. Currently acrylamide is reclassified as SVHC and now there are 15 items in the second batch. The detailed list of the 15 substances is as follows: Substance Name CAS No. Common Uses Anthracene Oil 90640-80-5 Rubber products, rubber oil, tires Anthracene Oil, Anthracene Paste, Light Oil 91995-17-4 Anthracene Oil, Anthracene Paste, Anthracene Distillate 91995-15-2 Anthracene Oil, Anthracene Containing Little Anthracene 90640-82-7 Anthracene Oil. Anthracene paste 90640-81-6 High-temperature coal tar pitch 659969-93-2 Used in paints, plastics, rubber Acrylamide 79-06-1 Flocculant, adhesive, soil conditioner, paper-making auxiliary agent, fiber modification and resin processing agent Aluminum silicate refractory ceramic fiber - Industrial insulation, sealing and anticorrosion materials; insulating and heat-insulating materials for electric heating devices; insulating and heat-insulating materials for instrumentation and electric heating elements; heat-insulating materials for automotive industry; insulating and heat-insulating materials for instrumentation and electric heating elements. Insulation materials; heat insulation materials for automotive industry Zirconia Aluminum Silicate Refractory Ceramic Fibers - 2,4-Dinitrotoluene 121-14-2 Manufacture of dye intermediates, explosives, paints, coatings Diisobutyl phthalate 84-69-5 Plasticizer for resin and rubber, widely used in plastics, rubber, paints and lubricants, emulsifiers, and other industries Lead chromate 7758-97-6 Can be used as a yellow pigment, Oxidizer and match composition, pigment of oil synthetic resin paint, printing ink, watercolor and oil paint, coloring agent of color paper, rubber and plastic products Molybdenum Chromium Red (C.I. Pigment Red 104) 12656-85-8 Used for coloring of paints, inks and plastics Lead Chromium Yellow (C.I. Pigment Yellow 34) 1344-37-2 Used in the manufacture of paints, inks, color pastes, literary and educational supplies, plastics, Plastic powder, rubber, oil pigments and other coloring Tris (2-chloroethyl) phosphate 115-96-8 Flame retardant, flame retardant plasticizers, metal extractants, lubricants, gasoline additives, and polyimide processing modifiers The third batch of the list of substances of very high concern SVHC III
At the Helsinki meeting that has just been concluded on June 9th and 10th, 2010, the European Union Chemicals Agency (ECHA) and the member states have agreed on a new list of substances of very high concern SVHC III, SVHC III. The European Chemicals Agency (ECHA) and the Member States' Committees (SMCs) agreed on eight SVHC substances that could become substances of very high concern (SVHC). These substances will be formally included in the SVHC Candidate List, which will be updated on ECHA's website, following ECHA's final decision on the Candidate List in which they will be included. Previously, ECHA published a proposal by three EU member states - Denmark, France and Germany - to categorize eight chemicals - tripolyethylene, boric acid, sodium tetraborate anhydrous, sodium tetraborate heptahydrate, sodium chromate, ammonium dichromate, and potassium dichromate - as SVHCs, all of which are carcinogens, teratogens and reproductive toxicants. Countries have until April 22, 2010 to publish comments on the hazardous properties of these eight substances, which will be reviewed by the SMCs at that time to determine whether to reach agreement with ECHA. On June 18, 2010, the third batch of SVHCs was officially added to the Candidate List, thus increasing the number of SVHCs on the Candidate List to 38 SVHCs. The eight new SVHCs are as follows: No. Substance Name EC No. CAS No. 1. trichloroethylene 201-167-4 79-01-6 2. boric acid 233-139-2/234-343-4 10043-35-3/11113-50-1 3. sodium tetraborate, anhydrous 215-540-4 1330-43-4
12179 -04-3
1303-96-4 4. sodium tetraborate, hydrate 235-541-3 12267-73-1 5. sodium chromate 231-889-5 7775-11-3 6. potassium chromate 232-140-5 7789-00-6 7. ammonium dichromate 232-143-1 7789-09-5 8. potassium dichromate 231-906-6 7778-9-50-5 8. potassium dichromate 231-906-6 7778-9-50-5 906-6 7778-50-9 On December 15, 2010, ECHA officially released the fourth batch of substances on the Candidate List for Authorization under REACH. The substances in this batch are 8 out of 11 substances proposed at the end of August, while 1,2,3-trichlorobenzene, 1,2,4-trichlorobenzene and 1,3,5-trichlorobenzene were excluded from this batch due to the lack of data. The number of substances on the Candidate List for authorization under REACH has now increased to 46. The eight substances in the fourth batch are all carcinogenic, mutagenic and/or toxic for reproduction (CMR) and are listed in Table 1 below. Table 1 The fourth batch of SVHC list Name EC No. and CAS No. Reason for proposal Possible use Cobalt sulfate (Cobalt sulfate) EC No. 233-334-2CAS No. 10124-43-3 CMRs are mainly used in the manufacture of other substances. Other uses include: catalysis and drying, surface treatment (e.g. electroplating), corrosion protection, production of pigments, decolorization (in glass, ceramics), batteries, animal feed, fertilizers, etc. Cobalt nitrate (Cobalt dinitrate) EC No. 233-402-1CAS No. 10141-05-6CMR is mainly used in the manufacture of other chemicals and catalysts. It is also used in surface treatment and batteries. Cobalt carbonate (Cobalt carbonate) EC No. 208-169-4CAS No. 513-79-1CMR is mainly used in the manufacture of catalysts, but also a small amount of feed additives, the manufacture of other chemicals, the manufacture of pigments and adhesives Cobalt acetate (Cobalt diacetate) EC No. 200-755-8CAS No. 71-48- 7CMR is mainly used in the manufacture of catalysts, but also used in small quantities in the manufacture of other chemicals, surface treatment, alloys, the manufacture of pigments, drying, rubber adhesives and feed additives 2-Methoxyethanol (2-Methoxyethanol) EC No. 203-713-7CAS No. 109-86-4CMR is mainly used as a solvent, chemical intermediates and fuel additives 2-Ethoxyethanol (2-Ethoxyethanol) EC No. 203-713-7CAS No. 109-86-4CMR is mainly used as a solvent, chemical intermediate and fuel additives Ethanol (2-Ethoxyethanol) EC No. 203-804-1CAS No. 110-80-5CMR Mainly used as a solvent, chemical intermediates Chromium trioxide (Chromium trioxide) EC No. 215-607-8CAS No. 1333-82-0CMR Used in metal surface treatment and preservation of aquatic wood Chromium trioxide and its oligomers produce acid Chromic acid Dichromic acid Chromic acid and oligomers of dichromic acid EC No. 231-801-5CAS No. 7738-94-5EC No. 236-881-5CAS No. 13530-68-2-CMR When chromium trioxide is dissolved in water it produces such substances. Chromium trioxide exists primarily as an aqueous solution, so these substances are used in the same way as chromium trioxide.
Fourth List of Substances of Very High Concern (SVHC) SVHC IV
On December 15, 2010, the European Chemicals Agency (ECHA) added 8 new substances to the SVHC Candidate List, thus increasing the number of SVHCs to 46: No. SVHC List of Substances of Concern (SVHC) Purpose Substance Name(Chinese) Substance Name(En) EC Number CAS Number 1 Cobalt sulfate Sulfuric acid,cobalt(2+) salt (1:1) 233-334-2 10124-43-3 Manufacture of other chemicals, more commonly used as catalysts, desiccants, surface treatment agents (e.g., electroplating), anticorrosion, coloring, decoloration, batteries, etc. 2 Cobalt cobalt nitrate cobaltous nitrate 233-402-1 10141-05-6 Production of other chemicals, more commonly used as catalysts, surface treatment, batteries, etc. 3 Cobaltous carbonate 208-169-4 513-79-1 Production of other chemicals, used as catalysts, food additives, coloring, adhesives, etc. 4 Cobaltous acetate acetate 200-755-8 71-48-7 Production of other chemicals, used as catalysts, surface treatment, alloys, pigments, dyes, rubber, glue, food additives. 5 2- Methoxyethanol Ethanol, 2-methoxy-,calcium salt (2:1); 203-713-7 109-86-4 Pigment, catalyst and used in ceramic industry 6 2-ethoxyethanol 2-(2-methoxyethoxy)ethanol 203-804-1 110-80-5 Ceramic glaze and Paint drying agent, also used in electroplating, alkaline batteries, production of cobalt-containing pigments and other cobalt products, also used as catalysts, analytical reagents, feed additives, tire adhesives, Lidl powder additives 7 Chromium trioxide and Chromium trioxide 215-607-8 1333-82-0 Metal finishing agents, fixing agents for aqueous wood preservatives 8 Chromic acid / dichromic acid / chromic acid and dichromic acid oligomers Chromic acid / dichromic acid and dichromate oligomers Chromic acid oligomer Chromic acidDichromic acid 7738-94-513530-68-2 Chromium trioxide produces chromic acid and dichromic acid when it is dissolved in water; chromium trioxide is in most cases an aqueous solution, so chromic acid and dichromic acid are used for the same purposes as chromium trioxide. That is, it is used for metal reprocessing and wood preservative stabilizers The fifth batch of Substances of Very High Concern (SVHC) list SVHC V
On June 20, 2011, under the unified endorsement of the member states, the European Chemicals Agency (ECHA) formally added seven substances to the Candidate List of SVHC, and at the same time revised the hazards of cobalt chloride, which was a previously identified SVHC substance. This is the fifth batch of SVHC Candidate List officially announced, together with the previous four batches of SVHC Candidate Substances, the total number of substances in the Candidate List has now reached 53.
New and Adjusted SVHC Candidate Substances Substance Name EC No. CAS No. Proposed SVHC Properties Potential Applications Ethylene Glycol Ethyl Ether Acetate 203-839-2 111-15-9 Article 57(c), Toxicity of Reproduction Solvents in the paint and chemical industries, intermediates in the production of cyanoacrylate adhesives. Strontium chromate 232-142-6 7789-06-2 Article 57(a), Carcinogenic Buffering agent in hybrid aviation/aerospace coatings, used in steel and aluminum coil and automotive coatings 1,2-Benzenedioic acid-di(C7-11 branched and straight chain) alkyl (alcohol) ester 271-084-6 68515-42-4 Article 57(c), Reproductive toxicity PVC, foam, adhesives and Plasticizers in coatings Biamine also known as: hydrazine 206-114-9 302-01-2
7803-57-8 Rule 57(a), Carcinogenic Intermediate in the manufacture of hydrazine derivatives, as a monomer in polymerization reactions, as a preservative in water treatment, metal and chemical refining, and as a propellant for aerospacecraft and as a fuel for military (emergency) power units. 1-Methylpyrrolidone 212-828-1 872-50-4 Section 57(c), Reproductive Toxicity Solvent for coatings and detergent products in the manufacture of electrical and electronic equipment, also used in applications with the semiconductor industry, in petrochemicals, pharmaceuticals and agrochemicals. 1,2,3-Trichloropropane 202-486-1 96-18-4 Article 57(a) and (c), Carcinogens and reproductive toxicity Intermediate in chlorinated solvents and agricultural production, also used as a monomer, formerly used as a remover and degreaser for paints and varnishes. Diisoheptyl phthalate 276-158-1 71888-89-6 Article 57(c), Reproductive toxicity Plasticizer in PVC, sealants, paints and printing inks. Cobalt chloride* 231-589-4 7646-79-9 Section 57(c), Reproductive Toxicity Intermediate in the manufacture of cobalt compounds, used in tire adhesives, organic textile dyes, paint dryers, used in surface treatment processes for glass and ceramic sanitary ware, colorants or discolors, used in piezoresistors, magnets, or humidity indicators. Sixth List of Substances of Very High Concern SVHC VI
On December 19, 2011, the European Chemicals Agency ECHA issued a notice officially announcing the sixth batch of 20 SVHCs.■ Sixth List of SVHCs and Uses: ■ Substances CAS NO. EC NO. SVHC Classification Potential Uses Chromium Chromate 24613-89-6 246-356-2 CMR Class 2 carcinogen Used in metal surface mixtures in industries such as aerospace, steel and aluminum coatings. Zinc Potassium Chromate Hydroxide 11103-86-9 234-329-8 CMR Class 2 Carcinogen Used in coatings for aviation/aerospace, steel, aluminum coils, automotive, and more. Zinc Yellow 49663-84-5 256-418-0 CMR Class 2 Carcinogen Automotive coatings, coatings for aerospace. Aluminosilicate Refractory Ceramic Fibers (RCF) - - CMR2 Carcinogen Refractory Ceramic Fiber Sets are used primarily in high temperature fire protection, industrial applications (industrial furnace and equipment fire protection, automotive and aerospace equipment) and construction, production of fire protection equipment Zirconia Aluminosilicate Refractory Ceramic Fibers (Zr-RCF) - - CMR2 Carcinogen Refractory Ceramic Fiber Sets are used primarily in high temperature fire protection, industrial applications ( Industrial furnace and equipment fire protection, automotive and aerospace equipment) and construction, production of fire protection equipment Polymer of formaldehyde and aniline 25214-70-4 500-036-1 CMR2 Carcinogen Primarily used in the production of other substances and, to a lesser extent, in epoxy resin curing agents Bis(2-methoxyethyl) phthalate 117-82-8 204-212-6 CMR2 Reproductive Toxicity Substances ECHA has not received any registrations for this substance. Main uses Plasticizer in plastic products, paints, pigments including printing inks. o-Methoxyaniline 90-04-0 201-963-1 CMR Class 2 Carcinogen Mainly used in the production of dyes for tattoos and coloring papers, polymers and aluminum foils P-tert-octylphenol 140-66-9 205-426-2 Substance with the same toxicity Used in the production of polymer formulations and polyoxyethylene ethers. Also used in adhesives, coatings, inks and as a component of rubber. 1,2-Dichloroethane 107-06-2 203-458-1 CMR2 Carcinogen Used in the manufacture of other substances and, in small amounts, as a solvent in the chemical and pharmaceutical industries. Diethylene glycol dimethyl ether 111-96-6 203-924-4 CMR2 carcinogen Mainly used as a reaction reagent in chemistry, but also as a battery electrolytic solution and in other products such as sealants, adhesives, fuels, and automotive care products Arsenic acid, pro-arsenic acid 7778-39-4 231-901-9 CMR2 carcinogen Mainly used in ceramic glass melting and laminate printing Calcium arsenate 7778-44-1 231-904-5 CMR2 carcinogen Raw material for the production of copper, lead and precious metals, mainly used in copper smelting and as a precipitant for the production of arsenic trioxide Lead arsenate 3687-31-8 222-979-5 CMR1 reproductive toxicant & CMR2 carcinogen Raw material for the production of copper, lead and precious metals N,N-Dimethylacetamide (DMAC) 127-19-5 204-826-4 CMR2 reproductive toxicant Used as a solvent and in the production of various substances and fibers. Also used in reagents, industrial coatings, polyimide films, paint strippers and ink removers 4,4'-Diamino-3,3'-dichlorodiphenylmethane (MOCA) 101-14-4 202-918-9 CMR2 carcinogen Mainly used in the production of resin curing agents and polymers, as well as in architecture and art Phenolphthalein 77-09-8 201-004-7 CMR2 carcinogen Mainly used in laboratory reagents and the production of various substances, as well as in the production of fibers. Carcinogenic substances Mainly used in laboratory reagents, PH test strips and medical products Lead diazide 13424-46-9 236-542-1 CMR2 Reproductive toxicants Mainly used as initiators for detonators and pyrotechnic devices in civilian and military starters and booster devices 2,4,6-trinitrobenzene diphenol lead 15245-44-0 239-290-0 CMR2 Reproductive toxicants Substance Primarily used in primers for small-caliber rifle ammunition; also commonly used in military ammunition, powder actuators and for civilian detonators. Lead picrate 6477-64-1 229-335-2 CMR2 reproductive toxicant ECHA has not received any registration for this substance, lead picrate is a kind of explosive, which is used in small amount in the mixture of detonator By December 19th, 2011, ECHA has published a total of 73 substances of high concern. Ruixu Technology reminds all enterprises to do timely response to ensure the smooth export of products.