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2020-06-25

When an SVHC is present in 0.1% by weight equal to or greater than 0.1% of a given article that constitutes a more complex article, it is mandatory to inform the consumer and, subject to certain conditions, to notify the European Chemicals Agency (ECHA). In Switzerland the SVHC listed in Annex 3 ChemO are candidate substances for an inclusion in Annex 1.17 of the Chemical Risk Reduction Ordinance (ORRChem). Substances listed in Annex 1.17 ORRChem can only be placed on the market or used on a professional or commercial basis after a certain date in Switzerland with a granted exemption or in cases where an authorisation has been granted by the SVHC are defined in Article 57 of Regulation (EC) No 1907/2006 ("the REACH Regulation") and include substances which are: Carcinogenic, Mutagenic or toxic to Reproduction (CMR), meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC. Suppliers of mixtures of substances which contain more than 0.1% by weight of any SVHC must provide their customers with a safety data sheet on request.

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High Concern (SVHC) included in the Candidate list (Annex XIV o REACH) by 20201. The objective is to determine the relevance of the substances already recognised as SVHC and to identify potential new ones. To achieve this target, the Commission and ECHA with the support of Member States Under Article 7(2) ‘Notification of substances in articles’, an article producer or article importer shall notify ECHA if an SVHC on the Candidate List is present in an article with a concentration of more than 0.1% by weight, and the total quantity of the SVHC in all articles produced or imported, exceeds 1 metric ton per producer or importer per year. Except for the SVHC listed in Annex 1, the other SVHC are not present above 0.1% by weight in article of product listed above. Current number of substances in the SVHC candidate list = 211 1 1 Annex 1 2 Manufacture of Sterile Medicinal Products 3 Document map Section Number General overview 1. Scope Additional areas (other than sterile medicinal products) where the general principles of the annex can be applied.

The SVHC candidate list will be regularly updated from time to time.

When an SVHC is present in 0.1% by weight equal to or greater than 0.1% of a given article that constitutes a more complex article, it is mandatory to inform the consumer and, subject to certain conditions, to notify the European Chemicals Agency (ECHA).

Except for the SVHC listed in Annex 1, the other SVHC are not present above 0.1% by weight in article of product listed above. Current number of substances in the SVHC candidate list = 211 1 1 Annex 1 2 Manufacture of Sterile Medicinal Products 3 Document map Section Number General overview 1. Scope Additional areas (other than sterile medicinal products) where the general principles of the annex can be applied. 2.

When an SVHC is present in 0.1% by weight equal to or greater than 0.1% of a given article that constitutes a more complex article, it is mandatory to inform the consumer and, subject to certain conditions, to notify the European Chemicals Agency (ECHA).. Sufficient information on any SVHC present in your products, at the article level, above the 0.1% threshold, must be made available to the

Substances fulfilling one or more of the criteria defined in Article 57 of the EU REACH Regulation can be identified as "substances of very high concern" (SVHC) and put on the "candidate List for authorization" which is also called "REACH SVHC list". When an SVHC is present in 0.1% by weight equal to or greater than 0.1% of a given article that constitutes a more complex article, it is mandatory to inform the consumer and, subject to certain conditions, to notify the European Chemicals Agency (ECHA). In Switzerland the SVHC listed in Annex 3 ChemO are candidate substances for an inclusion in Annex 1.17 of the Chemical Risk Reduction Ordinance (ORRChem). Substances listed in Annex 1.17 ORRChem can only be placed on the market or used on a professional or commercial basis after a certain date in Switzerland with a granted exemption or in cases where an authorisation has been granted by the SVHC are defined in Article 57 of Regulation (EC) No 1907/2006 ("the REACH Regulation") and include substances which are: Carcinogenic, Mutagenic or toxic to Reproduction (CMR), meeting the criteria for classification in category 1 or 2 in accordance with Directive 67/548/EEC. Suppliers of mixtures of substances which contain more than 0.1% by weight of any SVHC must provide their customers with a safety data sheet on request. Manufacturers or importers of articles containing more than 0.1% by weight of any SVHC must provide their customers, and consumers on request, with adequate information on the safe use and disposal of the article, including the name of the Se hela listan på echa.europa.eu 1-methyl-2-pyrrolidone(NMP) (entry 71, added in April 2018) CMR substance in textile and footwear (entry 72, added in Oct 2018) Some substances are literally banned by REACH annex XVII. These substances include Polychlorinated terphenyls (PCTs),asbestos fibres, pentachlorophenol and and its salts and esters, and monomethyl-tetrachlorodiphenyl 2016-10-06 · REACH EC/1097-2006 SVHC Annex 1 Declaration of Conformity to include ECHA List updated 2016-06-20 (169 Substances) Article above threshold PPM above None N / A REACH EC/1097-2006 Annex XIV 'Authorisation List' Updated 2016-01-11 (31 substances) Article above threshold Application Authorisation for use Applied?

REACH. Notizie dall'ECHA. Agenzia europea per le. Substance name 1. CAS no. 2. Hazard 3.
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PPM above None None N / A N / A (SVHC) as defined in Article 33 (1) & (2) “Substances of Very High Concern” EC Title VII, Chapter 1 Article 57 and revised as noted below.1 In addition, AVX complies with the restrictions stated in Annex XVII of REACH.

Friskrivningsklausul. Echas målsättning är att se till att Echas webbplats och all List of substances included in Annex XIV of REACH ("Authorisation List"). 1 feb. 2019 — RoHS and REACH Directives of the European Union, see pages 1 & 2 of of Very High Concern (SVHC) for inclusion in Annex XIV of REACH,.
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farliga ämnen. Den är en del av den europeiska kemikalielagstiftningen, Reach. Om en vara innehåller mer än 0,1 viktprocent av ett ämne som finns på​ 

Principle General principles as applied to the manufacture of medicinal products. 3. Pharmaceutical Quality System (PQS) 2020-11-17 · Annex XIV: Requires Authorisation to use substance in the EU after sunset date. Requires communication to downstream recipients when over threshold (0.1% w/w at article level). Requires notification to ECHA when SVHC over threshold and imported over 1 ton annually and use not already registered. Annex 1, only. SGS SVHC SEA PROCEDuRE STEP 1 - DOCUMENT CHECK Clients must provide the following documentation: Bill of Materials (BOM) Exploded diagram Agreement letter STEP 2 - HIGH RISK COMPONENT IDENTIFICATION High risk components are identified by our SVHC experts.

1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear 271-093-5 68515-50-4 44 27/02/2023 27/08/2021 Toxic for reproduction (Article 57c) SVHC Add to REACH Annex XIV Dihexyl phthalate 201-559-5 84-75-3 45 27/02/2023 27/08/2021 Toxic for reproduction (Article 57c) D/SVHC Add to REACH Annex XIV

SVHCs on the Authorization List (Annex XIV) are drawn from the Candidate List. 1,2-Benzenedicarboxylic acid, dihexyl ester, branched and linear 271-093-5 68515-50-4 44 27/02/2023 27/08/2021 Toxic for reproduction (Article 57c) SVHC Add to REACH Annex XIV Dihexyl phthalate 201-559-5 84-75-3 45 27/02/2023 27/08/2021 Toxic for reproduction (Article 57c) D/SVHC Add to REACH Annex XIV 4 1,3-プロパンスルトン 1,3-propasesultone 1120-71-4 発がん性 5 ペルフルオロノナン酸 Perfluorononan-1-oic-acid and its sodium and ammonium salts 375-95-1 21049-39-8 4149-60-4 生殖毒性 PBT 表1 使用管理物質 No.II-1 REACH規則認可対象候補物質(SVHC)：2015年6月15日公表分 2013-08-01 · After the sunset date set in Annex XIV of the REACH Regulation, only companies holding an authorization can place on the market and/or use a substances included therein. Enhesa Fact Sheet on SVHC.

Aluminiosilicate, Refractory Ceramic Fibres EC 650-017-00-8 CHI-EHS45-0008-A Page 1 of . 1. REACH (SVHC) Declaration . Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH). Product Series/ Part Number Annex 1b LGB8245TI Lead (7439-92-1) Notification: Submit notification to European Chemical Agency (ECHA) if any SVHC on candidate list present in an article has a concentration above 0.1% (w/w) and the total amount of the SVHC exceeds 1 tonne per annum per producer or importer.