REACH Compliance policy

Transcription

1 REACH Compliance policy The Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH) is a European Community Regulation related to the safe use and identification of chemicals (Regulation (EC) Number 1907/2006). Reach entered into force on June 1, 2007 with the aim of improving the protection of human health and the environment through better and earlier identification of the intrinsic properties of chemical substances. REACH was aimed at streamlining and improving former European Union chemical legislation by replacing approximately 40 individual pieces of legislation and harmonizing with the remaining legislation. The new legislative framework under REACH shifts responsibility for the control and safety of chemicals from government authorities to industry and created the European Chemicals Agency to act as a central coordinator. Innovasic is an importer of articles as defined in the Regulation, however, registration requirements under Article 7 of REACH do not currently apply to articles imported by Innovasic into the European Union because: Substances are not present in the articles in quantities totaling over one ton per year Substances are not intended to be released under normal or reasonably foreseeable conditions of use Innovasic will continue to monitor REACH developments and will comply with any applicable requirements. As Substances of Very High Concern (SVHC s) are added to Annex XIV of the Regulation (Authorization List), Innovasic will assess whether both of the following conditions are met: 1. The substance is present in the articles in quantities over one (1) ton per year 2. The substances are present in Innovasic devices above a concentration level of 0.1% w/w. Innovasic shall comply with the requirements of Article 7(2) and article 33 of the Regulation, as necessary. For informational purposes, Innovasic has contacted its manufacturing suppliers and verified that Innovasic devices do not contain SVHC s. Table 1 below defines the substances published by the European Chemicals Agency (ECHA) on the current Candidate List and the concentration of each substance detected in the materials used to manufacture Innovasic devices.

2 Table 1: Candidate List of SVHCs Substance Name CAS Number EC Number %WW a,a-bis[4-(dimethylamino)phenyl]-4 (phenylamino)naphthalene-1-methanol (C.I. Solvent Blue 4) [with >/= 0.1% of Michler's ketone (EC No ) or Michler's base (EC No )] %- Not Intentionally Added N,N,N',N'-tetramethyl-4,4'-methylenedianiline (Michler s base) %- Not Intentionally Added 1,3,5-tris[(2S and 2R)-2,3-epoxypropyl]- 1,3,5-triazine-2,4,6-(1H,3H,5H)-trione (b- TGIC) %- Not Intentionally Added Diboron trioxide %- Not Intentionally Added 1,2-bis(2-methoxyethoxy)ethane (TEGDME; triglyme) %- Not Intentionally Added 4,4'-bis(dimethylamino)-4''- (methylamino)trityl alcohol [with >/= 0.1% of Michler's ketone (EC No ) or Michler's base (EC No )] %- Not Intentionally Added Lead(II) bis(methanesulfonate) %- Not Intentionally Added Formamide %- Not Intentionally Added [4-[4,4'-bis(dimethylamino) benzhydrylidene]cyclohexa-2,5-dien-1- ylidene]dimethylammonium chloride (C.I. Basic Violet 3) [with >/= 0.1% of Michler's ketone (EC No ) or Michler's base (EC No )] %- Not Intentionally Added 1,2-dimethoxyethane; ethylene glycol dimethyl ether (EGDME) %- Not Intentionally Added [4-[[4-anilino-1-naphthyl][4- (dimethylamino)phenyl]methylene]cyclohexa- 2,5-dien-1-ylidene] dimethylammonium chloride (C.I. Basic Blue 26) [with >/= 0.1% of Michler's ketone (EC No ) or Michler's base (EC No )] %- Not Intentionally Added 1,3,5-Tris(oxiran-2-ylmethyl)-1,3,5- triazinane-2,4,6-trione (TGIC) %- Not Intentionally Added 4,4'-bis(dimethylamino)benzophenone (Michler s ketone) %- Not Intentionally Added 4-(1,1,3,3-tetramethylbutyl)phenol %- Not Intentionally Added N,N-dimethylacetamide %- Not Intentionally Added Phenolphthalein %- Not Intentionally Added Lead diazide, Lead azide %- Not Intentionally Added Lead dipicrate %- Not Intentionally Added 1,2-dichloroethane %- Not Intentionally Added Calcium arsenate %- Not Intentionally Added Dichromium tris(chromate) %- Not Intentionally Added 2-Methoxyaniline; o-anisidine %- Not Intentionally Added

3 Pentazinc chromate octahydroxide %- Not Intentionally Added Arsenic acid %- Not Intentionally Added Potassium hydroxyoctaoxodizincatedichromate %- Not Intentionally Added Formaldehyde, oligomeric reaction products with aniline %- Not Intentionally Added Lead styphnate %- Not Intentionally Added Trilead diarsenate %- Not Intentionally Added Zirconia Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number in Annex VI, part 3, table 3.1 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the three following conditions: a) oxides of aluminium, silicon and zirconium are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (µm). c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight 0%- Not Intentionally Added Bis(2-methoxyethyl) phthalate %- Not Intentionally Added Aluminosilicate Refractory Ceramic Fibres are fibres covered by index number in Annex VI, part 3, table 3.1 of Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, and fulfil the three following conditions: a) oxides of aluminium and silicon are the main components present (in the fibres) within variable concentration ranges b) fibres have a length weighted geometric mean diameter less two standard geometric errors of 6 or less micrometres (µm) c) alkaline oxide and alkali earth oxide (Na2O+K2O+CaO+MgO+BaO) content less or equal to 18% by weight 0%- Not Intentionally Added Bis(2-methoxyethyl) ether %- Not Intentionally Added 2,2'-dichloro-4,4'-methylenedianiline %- Not Intentionally Added Cobalt dichloride %- Not Intentionally Added 1,2-Benzenedicarboxylic acid, di-c6-8- branched alkyl esters, C7-rich %- Not Intentionally Added 1,2-Benzenedicarboxylic acid, di-c7-11- branched and linear alkyl esters %- Not Intentionally Added Strontium chromate 6/2/ %- Not Intentionally Added 1-Methyl-2-pyrrolidone %- Not Intentionally Added 1,2,3-Trichloropropane %- Not Intentionally Added 2-Ethoxyethyl acetate %- Not Intentionally Added

4 Hydrazine , %- Not Intentionally Added Cobalt(II) diacetate %- Not Intentionally Added Cobalt(II) sulphate %- Not Intentionally Added 2-Ethoxyethanol %- Not Intentionally Added Acids generated from chromium trioxide and their oligomers. Names of the acids and their oligomers: Chromic acid, Dichromic acid, Oligomers of chromic acid and dichromic acid , , %- Not Intentionally Added 2-Methoxyethanol %- Not Intentionally Added Chromium trioxide %- Not Intentionally Added Cobalt(II) carbonate %- Not Intentionally Added Cobalt(II) dinitrate %- Not Intentionally Added Trichloroethylene %- Not Intentionally Added Potassium dichromate %- Not Intentionally Added Tetraboron disodium heptaoxide, hydrate %- Not Intentionally Added Ammonium dichromate 9/5/ %- Not Intentionally Added Boric acid , , %- Not Intentionally Added Sodium chromate 11/3/ %- Not Intentionally Added Disodium tetraborate, anhydrous , , %- Not Intentionally Added Potassium chromate %- Not Intentionally Added Acrylamide %- Not Intentionally Added Lead sulfochromate yellow (C.I. Pigment Yellow 34) %- Not Intentionally Added Lead chromate molybdate sulphate red (C.I. Pigment Red 104) %- Not Intentionally Added Anthracene oil %- Not Intentionally Added 2,4-Dinitrotoluene %- Not Intentionally Added Anthracene oil, anthracene paste, anthracene fraction %- Not Intentionally Added Anthracene oil, anthracene-low %- Not Intentionally Added Tris(2-chloroethyl)phosphate %- Not Intentionally Added Diisobutyl phthalate %- Not Intentionally Added Lead chromate %- Not Intentionally Added Anthracene oil, anthracene paste %- Not Intentionally Added Pitch, coal tar, high temp %- Not Intentionally Added Anthracene oil, anthracene paste,distn. lights %- Not Intentionally Added Lead hydrogen arsenate %- Not Intentionally Added Benzyl butyl phthalate (BBP) %- Not Intentionally Added

5 Bis (2-ethylhexyl)phthalate (DEHP) %- Not Intentionally Added 5-tert-butyl-2,4,6-trinitro-m-xylene (musk xylene) %- Not Intentionally Added Diarsenic trioxide %- Not Intentionally Added Bis(tributyltin)oxide (TBTO) %- Not Intentionally Added Triethyl arsenate %- Not Intentionally Added Diarsenic pentaoxide %- Not Intentionally Added Sodium dichromate , %- Not Intentionally Added Dibutyl phthalate (DBP) %- Not Intentionally Added 4,4'- Diaminodiphenylmethane (MDA) %- Not Intentionally Added Alkanes, C10-13, chloro (Short Chain Chlorinated Paraffins) %- Not Intentionally Added Anthracene %- Not Intentionally Added Hexabromocyclododecane (HBCDD) and all major diastereoisomers identified: Alphahexabromocyclododecane Betahexabromocyclododecane Gammahexabromocyclododecane , ( ) ( ) ( ) and %- Not Intentionally Added Notice of Disclaimer The information disclosed to you hereunder (the Information ) is provided AS-IS with no warranty of any kind, express or implied. Innovasic does not assume any liability arising from you use of the information. You are responsible for obtaining any rights you may require for your use of this Information. Innovasic reserves the right to make changes, at any time, to the Information without notice and at its sole discretion. Innovasic assumes no obligation to correct any errors contained in the Information or to advise you of any corrections or updates. Innovasic expressly disclaims any liability in connection with technical support or assistance that may be provided to you in connection with the Information. INNOVASIC MAKES NO OTHER WARRANTIES, WHETHER EXPRESS, IMPLIED, OR STATUTORY, REGARDINGTHE INFORMATION, INCLUDING ANY WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NONINFRINGEMENT OF THIRD-PARTY RIGHTS.

6 Revision History Table 2 presents the sequence of revisions to document IA Table 2 Revision History Date Revision Description of Revisions Approved By March 3, Initial release of REACH Compliance policy August 18, With this revision, the policy has been placed under document control. This revision also includes additions to the SVHC list since the March 2009 version. February 23, Updated Policy to include those items added to the list since August September 9, Updated Policy to include those items added through June 2012