CE技術文件

Objective

The purpose of this regulation is to ensure a high level of protection of human health and the environment. It shall apply without prejudice to Community workplace and environmental legislation. There are exemptions on medical, veterinary, alimentary and cosmetic products, polymers and some on-site isolated intermediates.

Definitions

The following terms are defined: substance, mixture, article, producer of an article, polymer, monomer, registrant, manufacturing, manufacturer, import, importer, placing on the market, downstream user, distributor, intermediate, site, actors in supply chain, Agency, competent authority, phase-in substance, notified substance, product and process orientated research and development, scientific research and development, use, registrant's own use, full study report, robust study summary, study summary, per year, restriction, supplier and recipient of a substance / mixture / article, SME, exposure scenario, use and exposure category, substances which occur in nature, not chemically modified substance, alloy.

Contents

Substances that are subject to this regulation, on their own, in mixtures or in articles:

in quantities of one tonne or more per year;
intended to be released under normal or reasonably foreseeable conditions of use,

shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions where this is required.不得製造/販賣/存放於市場上,除非----

Save where this Regulation provides otherwise, any manufacturer or importer of a substance shall submit a registration to the European Chemicals Agency in Helsinki. The regulation details the duties of the Agency, the procedure of registration and the sharing of existing knowledge.

There are exemptions(豁免) from the general obligation to register for product and process orientated research and development.

Without prejudice(無侵犯) to Article 4 of Directive 98/24/EC,(本文)(摘要) a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in quantities of 10 tonnes or more per year per registrant. A chemical safety assessment of a substance shall include the following steps:

human health hazard assessment
physicochemical hazard assessment
environmental hazard assessment
persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment.

If a substance meets the criteria for classification as dangerous or is assessed to be a PBT or vPvB, the chemical safety assessment shall include additional steps.

Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommend them in the safety data sheets which he supplies.

Certain plant protection substances and biocidal products on which information was previously compiled need not be re-registered. Registration of on-site and transported isolated intermediates may require less data, if certain provisions are fulfilled.

The supplier of a substance or a mixture shall provide the recipient of the substance or ation with a safety data sheet (SDS) compiled in accordance with Annex II:

for substances classified as dangerous or
for PBT or vPvB or
for substances on the candidate list compiled by the Agency.

The supplier shall provide the recipient at his request with a safety data sheet where a ation does not meet the criteria for classification as dangerous, but contains substance(s) in a given concentrations:

posing human health or environmental hazards or
PBT or vPvB or
included in the candidate list compiled by the Agency or
for which there are Community workplace exposure limits.

The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market. The regulation details the obligatory headings of the SDSs. A SDS shall be provided free of charge on paper or electronically. Suppliers shall update the SDS without delay if:

new information on risk management or on hazards becomes available
an authorisation has been granted or refused
a restriction has been imposed.

Information on substances for which SDSs are not required must be communicated accordingly as well. Workers and their representatives shall be granted access by their employer to the information on the substances or mixture that they use or may be exposed to in the course of their work.

Each manufacturer, importer, downstream user and distributor must keep every information compiled, for at least 10 years after cessation of production, supply or use.

In making a use known, the downstream user shall provide sufficient information to allow the manufacturer, importer or supplier of the substance, to prepare an exposure scenario, or if appropriate a use and exposure category, for his use in the chemical safety assessment. If this use cannot be incorporated, the Agency and the downstream user must be informed. A downstream user shall prepare a chemical safety report ( Annex XII) for any use outside the conditions described in an exposure scenario or, if appropriate, for a use and exposure category communicated to him in a safety data sheet or for any use his supplier advises against. Downstream users shall keep their chemical safety report up to date and available.

The regulation details the evaluation process and authorisation. Holders of an authorisation as well as downstream users shall include the authorisation number on the label before they place the substance or a mixture containing the substance on the market for an authorised use. Substances in Annex XVII shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction. This shall not apply to scientific research and development. The regulation details the restrictions process.

The Secretariat of the Agency shall:

make the information identified in the database(s) publicly available, free of charge, over the Internet;
provide technical and scientific guidance and tools for the operation of this regulation;
advise and assist manufacturers and importers in registration.

This Regulation shall not apply to:

radioactive substances;
substances, which are subject to customs supervision and are in temporary storage, etc.;
non-isolated intermediates;
the carriage of dangerous substances;
waste.

No risk (e.g. water, sugar. Annex IV), unmodified, non-dangerous substances which occur in nature (e.g. ores, vegetable oils) and byproducts of unintended reactions (Annex V) are exempted from registration and evaluation.

Annexes

Annex I: General provisions for assessing substances and preparing chemical safety reports
Annex II: Guide to the compilation of safety data sheets
Annex III: Criteria for substances registered in quantities between 1 and 10 tonnes
Annex IV: And V Exemptions from the obligation to register in accordance with article 2(7)(a) and (b)
Annex VI: Information requirements referred to in article 10
Annex VII/VIII/IX/X: Standard information requirements for substances manufactured or imported in quantities of one tonne or more / 10 tonnes or more / 100 tonnes or more / 1 000 tonnes or more
Annex XI: General rules for adaptation of the standard testing regime set out in annexes VII to X
Annex XII: General provisions for downstream users to assess substances and prepare chemical safety reports
Annex XIII: criteria for the identification of persistent, bioaccumulative and toxic substances, and very persistent and very bioaccumulative substances
Annex XIV: List of substances subject to authorisation
Annex XV: Dossiers
Annex XVI: Socio-economic analysis
Annex XVII: restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles

服務日期	服務內容
2018\3\5	OSHA噪音法規台灣:職業安全衛生設施規則:第 300 條 America Noise permisible level(News) Directive 2003/10/EC - noise REACH Legislation(Regulation (EC) No 1907/2006 - REACH)(內網)Registration註冊, Evaluation評估, Authorisation授權 and Restriction管制 of Chemicals 針對高度關切物質，業者應特別注意REACH的成品通報與供應鏈溝通規定：Substances of Very High Concern(SVHCs)Without prejudice to Article 4 of Directive 98/24/EC(勞工衛生安全法規)(guide)(本文), a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in quantities of 10 tonnes or more per year per registrant. A chemical safety assessment of a substance shall include the following steps: 【通報規定適用條件】同時滿足下列四項描述者；(評估步驟) (regulation (EC) No 1907/2006)(內網) 物質是可能列入授權的高度關切物質（第59條）；且個別製造商或進口商成品中的成品中高度關切物質年總量超過1噸；且高度關切物質在成品中的濃度超過0.1%(W/W)；且成品正常或合理預期使用，包括棄置時，無法排除人體與環境暴露於高度關切物質之下【供應鏈溝通】【公司宣告 doc】若成品中含高度關切物質濃度達0.1%(w/w)，製造商與進口商必須進行供應鏈資訊傳遞，提供顧客與供應商足夠的成品中高度關切物質安全使用資訊，當消費者要求提供安全使用資訊時，成品供應商應在45天內無償提供。參考資料 EU REACH 高度關切物質清單(另開視窗) EU REACH高度關切物質清單-中文版pdf下載 Directive 98/24/EC - risks related to chemical agents at work Steps
	Regulation (EC) No 1907/2006 - REACH of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) and establishing a European Chemicals Agency Objective The purpose of this regulation is to ensure a high level of protection of human health and the environment. It shall apply without prejudice to Community workplace and environmental legislation. There are exemptions on medical, veterinary, alimentary and cosmetic products, polymers and some on-site isolated intermediates. *Definitions* The following terms are defined: substance, mixture, article, producer of an article, polymer, monomer, registrant, manufacturing, manufacturer, import, importer, placing on the market, downstream user, distributor, intermediate, site, actors in supply chain, Agency, competent authority, phase-in substance, notified substance, product and process orientated research and development, scientific research and development, use, registrant's own use, full study report, robust study summary, study summary, per year, restriction, supplier and recipient of a substance / mixture / article, SME, exposure scenario, use and exposure category, substances which occur in nature, not chemically modified substance, alloy. Contents Substances that are subject to this regulation, on their own, in mixtures or in articles: in quantities of one tonne or more per year; intended to be released under normal or reasonably foreseeable conditions of use, shall not be manufactured in the Community or placed on the market unless they have been registered in accordance with the relevant provisions where this is required.不得製造/販賣/存放於市場上,除非---- Save where this Regulation provides otherwise, any manufacturer or importer of a substance shall submit a registration to the European Chemicals Agency in Helsinki. The regulation details the duties of the Agency, the procedure of registration and the sharing of existing knowledge. There are exemptions(豁免) from the general obligation to register for product and process orientated research and development. Without prejudice(無侵犯) to Article 4 of Directive 98/24/EC,(本文)(摘要) a chemical safety assessment shall be performed and a chemical safety report completed for all substances subject to registration in quantities of 10 tonnes or more per year per registrant. A chemical safety assessment of a substance shall include the following steps: human health hazard assessment physicochemical hazard assessment environmental hazard assessment persistent, bioaccumulative and toxic (PBT) and very persistent and very bioaccumulative (vPvB) assessment. If a substance meets the criteria for classification as dangerous or is assessed to be a PBT or vPvB, the chemical safety assessment shall include additional steps. Any registrant shall identify and apply the appropriate measures to adequately control the risks identified in the chemical safety assessment, and where suitable, recommend them in the safety data sheets which he supplies. Certain plant protection substances and biocidal products on which information was previously compiled need not be re-registered. Registration of on-site and transported isolated intermediates may require less data, if certain provisions are fulfilled. The supplier of a substance or a mixture shall provide the recipient of the substance or ation with a safety data sheet (SDS) compiled in accordance with Annex II: for substances classified as dangerous or for PBT or vPvB or for substances on the candidate list compiled by the Agency. The supplier shall provide the recipient at his request with a safety data sheet where a ation does not meet the criteria for classification as dangerous, but contains substance(s) in a given concentrations: posing human health or environmental hazards or PBT or vPvB or included in the candidate list compiled by the Agency or for which there are Community workplace exposure limits. The safety data sheet shall be supplied in an official language of the Member State(s) where the substance or mixture is placed on the market. The regulation details the obligatory headings of the SDSs. A SDS shall be provided free of charge on paper or electronically. Suppliers shall update the SDS without delay if: new information on risk management or on hazards becomes available an authorisation has been granted or refused a restriction has been imposed. Information on substances for which SDSs are not required must be communicated accordingly as well. Workers and their representatives shall be granted access by their employer to the information on the substances or mixture that they use or may be exposed to in the course of their work. Each manufacturer, importer, downstream user and distributor must keep every information compiled, for at least 10 years after cessation of production, supply or use. In making a use known, the downstream user shall provide sufficient information to allow the manufacturer, importer or supplier of the substance, to prepare an exposure scenario, or if appropriate a use and exposure category, for his use in the chemical safety assessment. If this use cannot be incorporated, the Agency and the downstream user must be informed. A downstream user shall prepare a chemical safety report ( Annex XII) for any use outside the conditions described in an exposure scenario or, if appropriate, for a use and exposure category communicated to him in a safety data sheet or for any use his supplier advises against. Downstream users shall keep their chemical safety report up to date and available. The regulation details the evaluation process and authorisation. Holders of an authorisation as well as downstream users shall include the authorisation number on the label before they place the substance or a mixture containing the substance on the market for an authorised use. Substances in Annex XVII shall not be manufactured, placed on the market or used unless it complies with the conditions of that restriction. This shall not apply to scientific research and development. The regulation details the restrictions process. The Secretariat of the Agency shall: make the information identified in the database(s) publicly available, free of charge, over the Internet; provide technical and scientific guidance and tools for the operation of this regulation; advise and assist manufacturers and importers in registration. This Regulation shall not apply to: radioactive substances; substances, which are subject to customs supervision and are in temporary storage, etc.; non-isolated intermediates; the carriage of dangerous substances; waste. No risk (e.g. water, sugar. Annex IV), unmodified, non-dangerous substances which occur in nature (e.g. ores, vegetable oils) and byproducts of unintended reactions (Annex V) are exempted from registration and evaluation. *Annexes* Annex I: General provisions for assessing substances and preparing chemical safety reports Annex II: Guide to the compilation of safety data sheets Annex III: Criteria for substances registered in quantities between 1 and 10 tonnes Annex IV: And V Exemptions from the obligation to register in accordance with article 2(7)(a) and (b) Annex VI: Information requirements referred to in article 10 Annex VII/VIII/IX/X: Standard information requirements for substances manufactured or imported in quantities of one tonne or more / 10 tonnes or more / 100 tonnes or more / 1 000 tonnes or more Annex XI: General rules for adaptation of the standard testing regime set out in annexes VII to X Annex XII: General provisions for downstream users to assess substances and prepare chemical safety reports Annex XIII: criteria for the identification of persistent, bioaccumulative and toxic substances, and very persistent and very bioaccumulative substances Annex XIV: List of substances subject to authorisation Annex XV: Dossiers Annex XVI: Socio-economic analysis Annex XVII: restrictions on the manufacture, placing on the market and use of certain dangerous substances, mixtures and articles
	EMPLOYERS' OBLIGATIONS Article 4 Determination and assessment of risk of hazardous chemical agents 1. In carrying out the obligations laid down in Articles 6(3) and 9(1) of Directive 89/391/EEC, the employer shall first determine whether any hazardous chemical agents are present at the workplace. If so, he shall then assess any risk to the safety and health of workers arising from the presence of those chemical agents, taking into consideration the following: - their hazardous properties, - information on safety and health that shall be provided by the supplier, (e.g. the relevant safety data sheet in accordance with the provisions of Directive 67/548/EEC or Directive 88/379/EEC), - the level, type and duration of exposure, - the circumstances of work involving such agents, including their amount, - any occupational exposure limit values or biological limit values established on the territory of the Member State in question, - the effect of preventive measures taken or to be taken, - where available, the conclusions to be drawn from any health surveillance already undertaken. The employer shall obtain additional information which is needed for the risk assessment from the supplier or from other readily available sources. Where appropriate, this information shall comprise the specific assessment concerning the risk to users established on the basis of Community legislation on chemical agents. 2. The employer must be in possession of an assessment of the risk in accordance with Article 9 of Directive 89/391/EEC, and shall identify which measures have been taken in accordance with Articles 5 and 6 of this Directive. The risk assessment shall be documented in a suitable form according to national law and practice, and may include a justification by the employer that the nature and extent of the risks related to chemical agents make a further detailed risk assessment unnecessary. The risk assessment shall be kept up-to-date, particularly if there have been significant changes which could render it out-of-date, or when the results of health surveillance show it to be necessary. 3. Certain activities within the undertaking or establishment, such as maintenance, in respect of which it is foreseeable that there is a potential for significant exposure, or which may result in deleterious effects to safety and health for other reasons, even after all technical measures have been taken, shall be included in the risk assessment. 4. In the case of activities involving exposure to several hazardous chemical agents, the risk shall be assessed on the basis of the risk presented by all such chemical agents in combination. 5. In the case of a new activity involving hazardous chemical agents, work shall only commence after an assessment of the risk of that activity has been made and any preventive measures identified have been implemented. 6. Practical guidelines for the determination and assessment of risk, and for their review and, if necessary, adjustment, shall be developed in accordance with Article 12(2).

Regulation (EC) No 1907/2006 - REACH