On REACH rules in EU [复制链接]

Hi, friends.
Do you have any referece standard for the REACH in EU, as was released in June 2008.
I need the english version. Thanks.
Looking forward to your kind reply.

http://ec.europa.eu/environment/chemicals/index.htm


Chemicals

In the early days of the European Community it was recognised that there was a need to protect the Community's environment and to create common standards to protect consumers in order to ensure the free circulation of goods among the Member States. For this reason, the first Community environment legislation dealt with products, amongst them dangerous chemicals.

However, in recent years, drawbacks of the current system have been identified and examined. The most important of these are:

  * 100.106 existing substances can be used without testing
  * burden of proof on public authorities
  * no efficient instrument to ensure safe use of the most problematic substances
  * lack of incentives for innovation, in particular of less hazardous substitutes

The REACH Regulation addresses the shortcomings of the current system. It relates mainly to the following legislation:

  *

    Directive on the Classification, Packaging and Labelling of Dangerous Substances
  *

    Directive on the Classification, Packaging and Labelling of Dangerous Preparations
  *

    Regulation on the Evaluation and Control of the Risks of Existing Substances
  *

    Directive on Restrictions on the Marketing and Use of certain Dangerous Substances and Preparations

A report on the operation of these 4 instruments was produced in 1998 (SEC/1998/1986).

de en fr

Many other linked measures have been adopted, dealing with Pesticides - divided into two major groups in Community legislation - Plant Protection Products and Biocides; Worker Protection; Prevention of Chemical Accidents and Reduction of Industrial Emissions e.g. Volatile Organic Compounds; Mercury, to form a network of environmental legislation concerning chemicals. In addition, work is progressing in particular on Endocrine Disrupting Chemicals and on Dioxins.

RISK MANAGEMENT OF PESTICIDES
– Plant protection products and biocides

Pesticides are chemical products that are used to destroy or otherwise control pests and other harmful organisms. There are significant economic and other benefits related to the use of pesticides, but they also cause concern for human health and the environment.

Pesticides contain one or more biologically active substances that have the controlling effect on the unwanted organisms. Unfortunately, these substances are often also harmful to non-target organisms. Therefore, in many countries, pesticides have been subject to strict control for long time already. Specific assessment and approval schemes have been established to prevent unacceptable effects on human health and the environment and to ensure that products are effective and suitable for their purpose.

In Community legislation, pesticides have been divided into two major groups, plant protection products and biocidal products. Products belonging to these groups need to be assessed and authorised before they can be placed on the market. In addition, certain pesticides are subject to prohibitions or restrictions and regulations concerning control of international trade. As many pesticides are deliberately released to the environment, they are also a source of surface and ground water pollution. Therefore they are a subject of water legislation as well. All in all, the sustainable use of pesticides is an issue recognised to be of major importance in the Sixth Environment Action Program.

http://ec.europa.eu/environment/chemicals/reach/reviews_en.htm

Commission review of Annexes I, IV, V, XI and XIII of REACH

Within the first 18 months after the entry into force of REACH (Regulation (EC) No. 1907/2006), the Commission has been tasked to carry out a number of reviews of the following Annexes of the Regulation:

  * Annex I
  * Annex IV
  * Annex V
  * Annex XI, and
  * Annex XIII

The Commission will involve Member States and other stakeholders on the reviews in a sub-group of the REACH Competent Authorities.

Following the reviews, and if appropriate, the Commission will prepare amendments to the relevant Annexes to take into account the results of the reviews.

Stakeholder consultation

The Commission engaged Member States and other stakeholders on the reviews in a sub-group of the REACH Competent Authorities (CA); the Competent Authority Sub Group for the Annexes (CASG (Annexes)).

The Commission asked for nominations by CA members and observers to enable consultation covering all the reviews. The following Member States: AT, BE, DE, DK, EE, ES, FI, FR, GR, IE, IT, LT, IT, NL, SE, UK, and observers: Norway, CEFIC, REACH Alliance, CONCAWE, WWF and ETUC, were nominated and selected.

Annex I

Annex I of Regulation (EC) No. 1907/2006 (REACH) sets out the details of how to carry out a Chemical Safety Assessment and document it in a Chemical Safety Report. The Annex has been supplemented by a technical guidance document on Information Requirements and Chemical Safety Assessment, available here.

Article 138(4) mandates the Commission to carry out a review of Annex I of REACH by 1 June 2008, with a view to proposing amendments, if appropriate. As an outcome of the review, the Commission services have concluded that it is currently not appropriate to propose an amendments to Annex I.

Annex IV

Annex IV of Regulation (EC) No. 1907/2006 (REACH) sets out substances that are exempted from the registration, evaluation and downstream user provisions of REACH because sufficient information is known about the substances that they are considered to cause minimum risk because of their intrinsic properties.

Substances included in Annex IV are exempted from registration (as well as downstream user requirements and evaluation) for all their possible uses irrespective of the tonnage they are manufactured or imported (currently or in the future). Annex IV essentially reproduces the list of substances exempt from the obligation to register under the present Existing Substances Regulation (Regulation (EEC) No. 793/93).

Article 138(4) mandates the Commission to carry out a review of Annex IV of REACH before 1 June 2008, with a view to proposing amendments, if appropriate. Recital 36 also requires the review of Annex IV to take into account the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes.

The Commission has agreed with the Member States and stakeholders a process for submission of proposals for amendments to Annex IV, criteria against which the proposals for amendment can be judged, documentation that should be provided and a timetable for completing this work. The relevant document can be found here.

On the basis of these criteria, 294 proposals for amendment by Member States and stakeholders have been received and evaluated by a consultant. Moreover, the consultant has also reviewed the existing entries in the Regulation as published in OJ L 396 of 30 December 2006 against these criteria. The final report by the consultant will be made available on this website.

As an outcome of the review, the Commission services have prepared a draft proposal for amending Annexes IV and V. After the vote in the REACH Committee on 5 June 2008, the proposal will be submitted to scrutiny by the European Parliament and Council pursuant to Article 133(4). It is foreseen that the adoption of this proposal will take place in October or November 2008.

Annex V

Annex V of Regulation (EC) No. 1907/2006 (REACH) sets out substances that are exempted from the registration, evaluation and downstream user provisions of REACH because registration is deemed inappropriate or unnecessary and their exemption does not prejudice the objectives of REACH.

Substances included in Annex V are exempted from registration (as well as downstream user requirements and evaluation) for all their possible uses irrespective of the tonnage at which they are manufactured or imported (currently or in the future). Annex V is mainly based on the reporting rules for the EINECS Inventory and reflect the experience in the operation of the Directive 67/548/EEC on classification, packing and labeling of dangerous substances, and are collected in the Manual of Decisions (MoD) to this Directive. In addition, Annex V contains a number of changes made during the legislative procedure for the adoption of REACH.

Article 138(4) mandates the Commission to carry out a review of Annex V of REACH before 1 June 2008, with a view to proposing amendments, if appropriate. Recital 36 also requires the review of Annex V to take into account the application of Article 2(7)(a) and (b) and Annex XI to substances derived from mineralogical processes.

The Commission has undertaken the review of Annex V, taking into account the comments received by Member States and stakeholders.

As an outcome of the review, the Commission services have prepared a draft proposal for amending Annexes IV and V. After the vote in the REACH Committee on 5 June 2008, the proposal will be submitted to scrutiny by the European Parliament and Council pursuant to Article 133(4). It is foreseen that the adoption of this proposal will take place in October or November 2008.

Annex XI

Annex XI sets out the general rules for adaptation of the standard testing regime (waiving) specified in the information Annexes. Part 3 of Annex XI deals with substance-tailored exposure-driven testing for sections 8.6 and 8.7 of Annex VIII, Annex IX and Annex X, where, on the basis of the exposure scenario(s) developed in the Chemical Safety Report, testing may be waived.

The Commission was given the task to adopt by 1 December 2008 practical criteria defining what constitutes adequate justification for waiving tests. Recital 38 gives guidance that the criteria should be based on experience gained through RIPs.

In May 2008, ECHA published the technical guidance document on Information Requirements and Chemical Safety Assessment, available on http://reach.jrc.it/docs/guidance_document/information_requirements_en.htm. On the basis of the experience reflected in this guidance document, the Commission services will elaborate an amendment of Annex XI to be adopted by 1 December 2008.

Annex XIII

Annex XIII sets out the criteria for the identification of persistent, bioaccumulative and toxic (PBT) substances, and very persistent and very bioaccumulative (vPvB) substances; it does not apply to inorganic substances.

Article 138(5) mandates the Commission to carry out a review of Annex XIII by 1 December 2008. Recital 76 requires the criteria in Annex XIII to be reviewed taking into account current and new experience in the identification of these substances and if appropriate amended with a view to ensuring a high level of protection of human health and the environment.

The experience reflected in the technical guidance document on Information Requirements and Chemical Safety Assessment (link to document at http://reach.jrc.it), from the PBT working group under Regulation (EC) No 793/93 and Directive 67/548/EEC and from the Regulation 850/2004 on Persistent Organic Pollutants will be reflected in the review of Annex XIII.

Stakeholder's comments concerning the review of Annex XIII should preferably be co-ordinated and channelled through the members and observers of the CASG Annexes (see above) with a copy to the Commission services (ENV-REACH-annexes@ec.europa.eu, ENTR-REACH-Annexes@ec.europa.eu).

http://ec.europa.eu/environment/chemicals/reach/preparing/index_en.htm

Preparing for REACH
REACH Implementation Projects (RIPS)

To enable a smooth transition from the existing chemicals legislation to REACH, the Commission has developed within an interim strategy a number of REACH Implementation Projects (RIPs) to ensure that all stakeholders, especially industry and public authorities, are adequately prepared for the practical application of the new system.

These Implementation Projects foresee the development of guidance documents and IT-tools for the European Chemicals Agency, for industry and the authorities of the Member States including 5 central areas:

RIP 1 – REACH Process description

RIP 2– REACH-IT: Development of the IT system to support the REACH implementation

RIP 3 – Guidance Documents: Development of guidance documents for industry

RIP 4 - Guidance Documents: Development of guidance documents for authorities

RIP 5/6 - Setting up the Agency

The European Chemicals Bureau (ECB) in Ispra has been given the responsibility to develop those tools and methodologies as it has the main practical experience from administering the practical implementation of the pre-REACH chemicals legislation, while DG ENV and DG ENTR ensure the political and legislative compatibility. The activities are coordinated closely with the main stakeholders i.e. Member States, Industry and NGOs.

In order to gain practical experience stakeholders were encouraged to co-operate in trying out aspects of the new system in so-called Strategic Partnerships.

For further details please visit the website of the European Chemicals Bureau or access the available guidance documents on the website of the European Chemicals Agency.

http://ec.europa.eu/environment/chemicals/reach/background/index_en.htm

REACH: History and Background
History of the adoption process for the new chemicals legislation

On 13th February, 2001, the European Commission adopted a White Paper setting out the strategy for a future Community Policy for Chemicals.

The European Commission's original legislative proposal on REACH COM(03) 644 (01) and COM(03) 644 (02) amending Directive 67/548/EEC was adopted on 29 October 2003 and was communicated to both the European Parliament and the Council in November 2003.

The work in the European Parliament has been led by the Committee on the Environment, Public Health & Food Safety, with – in first reading - the assistance of nine other parliamentary committees. The European Parliament adopted its first reading opinion on 17 November 2005.

The Council reached a Political Agreement for a Common Position (pdf 865KB) on 13 December 2005.

The Environment Council formally adopted the Common Position (pdf 1,7MB) (press release - pdf 312KB) on June 2006 which served as the basis of discussion during the second reading in the European Parliament, which started in September 2006.

A Commission Communication on the Common Position (COM (2006) 375) was adopted on 12 July 2006 and submitted to the European Parliament and Council allowing the second reading to commence.

The representatives of the European Parliament and the Council found a negotiated agreement of the final version of REACH in early December 2006. This agreement was subsequently endorsed at second reading in the European Parliament on 13 December 2006 (press release) and got finally adopted at the Environment Council on 18 December 2006 (press release).

The text of the law was published on 30 December 2006 in the Official Journal of the European Union L 396.

The new EU chemicals Regulation REACH entered into force on 1 June 2007 (press release). The new European Chemicals Agency in Helsinki, Finland, will be fully operational on 1 June 2008, in time for the industry's obligation to submit pre-registration dossiers for existing substances and registration dossiers for new substances.
Background

  * Impact Assessment

  * Stakeholder Consultation

http://ec.europa.eu/environment/chemicals/reach/glossary_en.htm

REACH glossary and abbreviations

C&L
   

Classification and Labelling

CAS
   

Chemical Abstract Service

Cefic
   

European Chemical Industry Council

CMRs
   

Carcinogenic, Mutagenic or Toxic (for reproduction)
Chemicals classified under Directive 67/548)

CSA
   

Chemical Safety Assessment

CSR
   

Chemical Safety Report

CSTEE
   

Scientific Committee on Toxicology, Ecotoxicology and Environment (CSTEE)

DNEL
   

Derived No-Effect Level

DU
   

Downstream Users

ECB
   

European Chemicals Bureau

ECVAM
   

JRC's European Centre for the Validation of Alternative Methods

EINECS
   

List of substances compiled in 1981 that today are considered "existing substances"

ELINCS
   

European List of Notified Chemical Substances

EMEA
   

European Medicines Agency

Endocrine disrupters
   

Substances of very high concern that mimic or inhibit the effects of hormones.

ESIS
   

European Chemical Substance Information System

EUSES
   

European Union System for the Evaluation of Substances

GHS
   

the UN's Globally Harmonised System of Classification and Labelling

GLP
   

Good Laboratory Practice

HPV
   

High Production Volume Chemicals

IARC
   

International Agency for Research on Cancer

ICCA
   

International Council of Chemical Associations

IFCS
   

Intergovernmental Forum on Chemical Safety

ILO
   

International Labour Organisation

in vitro-testing
   

Studies done with cell or tissue cultures

in vivo -testing
   

Studies done with live animals

IUCLID
   

International Uniform Chemical Information Database

IUPAC
   

International Union for Pure Applied Chemistry

JRC
   

Joint Research Centre

LCA
   

Life Cycle Assessment

LOEL
   

Lowest observed Effect Level

LVP
   

Low Production Volume Chemicals

MOS
   

Margins of safety

MS Cas
   

Member States Competent Authorities

NLP
   

No-Longer Polymers

NOAEL
   

No observed adverse effect level

NOEC
   

No observed effect concentration

NOEL
   

No observed effect level

ORATS
   

Online European Risk Assessment Tracking System

OSOR
   

One Substance, One Registration

OSPAR
   

Oslo - Paris Convention for the Protection of the Marine Environment of the North East Atlantic

PBT
   

Persistent, Bio-accumulative and Toxic

PEC
   

Predicted environmental concentration

PIC
   

Prior Informed Consent (the Rotterdam Convention of Prior Informed Consent sets up a system to control international trade in certain hazardous substances.

PNEC
   

Predicted No-Effect Concentration

Polymers
   

large molecules consisting of repeated chemical units (monomers)

POPs
   

Persistent Organic Pollutants

PPORD
   

Product and Process Oriented Research and Development

RA
   

Risk Assessment

RAR
   

Risk Assessment Report

REACH
   

Registration, Evaluation, Authorisation and Restriction of Chemicals

RIPs
   

REACH Implementation Projects

RMM
   

Risk Management Measures

SAICM
   

Strategic Approach to International Chemicals Management

SAR (Q)SAR
   

(Quantitative) Structure Activity Relationship

SDS
   

Safety Data Sheet - tool for information transfer for all dangerous substances

SEA
   

Socio-economic analysis

SIDS
   

Screening Information Data Set

SIEF
   

Substance Information Exchange Forum

SPORT
   

Strategic Partnership on REACH Testing

SVHC
   

Substance of Very High Concern

TGD
   

Technical Guidance Document

TSCA
   

Toxic Substance Control Act

UNCED
   

United Nations Conference on Environment and Development

UNEP
   

United Nations Environment Programme

UNICE
   

Union des Industries de la Communauté Européenne

UVCB
   

Substances of unknown variable composition, complex reaction products or biological materials

vPvB
   

Very Persistent, Very Bio-accumulative

WTO
   

World Trade Organisation

http://ec.europa.eu/environment/chemicals/reach/links_en.htm

Chemicals
European Chemicals Agency

  European Chemicals Agency logo

European Commission and other Agencies

  DG Enterprise and Industry

  DG Health and consumer protection

  European Chemicals Bureau

  European Foundation for the Improvement for living and working conditions

  European Food Safety Authority

  European Agency for Safety and Health at work

Other organisations

  European Environmental Bureau

  OECD eChemPortal - Global Portal to Information on Chemical Substances

International Actions

  International programme on Chemical safety

  United Nations Institute for Training and Research - Chemicals, Waste and Environmental Governance

  UNEPS Chemicals Programme (+ SAICM)

  Globally Harmonised System (GHS)

  The Rotterdam Convention

  Stockholm Convention

NGOs

  World Wide Fund for Nature

  Greenpeace

  Friends of the Earth

  International Chemicals secretariat

  The European Consumers’ organisation

  Health & Environment Alliance

EU Member States' Chemicals Policies

     

  Austria
     

  Federal Environment Agency

     

  Belgium
     

  Institut Bruxellois pour la Gestion de l’Environnement (IBGE)

  Federal Department of the Environment

     

  Cyprus
     

  Ministry of Agriculture, Natural Resources and Environment

     

  Bulgaria
     

  Ministry of Environment and Water

     

  Czech Republic
     

  Ministry of the Environment

     

  Denmark
     

  National Environmental Research Institute of Denmark

  Danish Environmental Protection Agency

     

  Estonia
     

  Ministry of the Environment

     

  Germany
     

  The Federal Environmental Agency

     

  Greece
     

  Hellenic Ministry for the Environment

     

  Hungary
     

  Ministry of Environment and Water

     

  Finland
     

  Ministry of the Environment

     

  France
     

  Ministry of Ecology and Sustainable Development

     

  Ireland
     

  Ministry for the Environment

  Environmental Protection Agency

     

  Italy
     

  Ministry of the Environment

     

  Latvia
     

  Ministry of Environment

     

  Lithuania
     

  Ministry of Environment

     

  Luxembourg
     

  Ministry of the Environment

     

  Malta
     

  Malta Environment and Planning Authority

     

  Poland
     

  Ministry of the Environment

     

  Portugal
     

  Ministry of the Environment

     

  Romania
     

  Ministry of Environment and Water Management

     

  Slovakia
     

  Slovak Environmental Agency

     

  Slovenia
     

  Ministry of Environment and Spatial Planning

  Environmental Agency of the Republic of Slovenia

     

  Spain
     

  Ministry of the Environment

     

  Sweden
     

  Swedish Environmental Protection Agency

     

  The Netherlands
     

  Ministry of the Environment

     

  United Kingdom
     

  Department for Environment, Food and Rural Affairs (DEFRA)

  Department of Trade and Industry


Other countries' Chemical Policies

     

  Canada
     

  Government of Canada

     

  Norway
     

  State of the Environment Norway

     

  Switzerland
     

  Federal Office for the Environment

     

  US
     

  Environmental Protection Agency - Pesticides, Toxics and Chemical Projects and Programs

  Environmental Protection Agency – Chemical Emergency Preparedness and Prevention

     

  * Last updated: 01/05/2008

Thank you very much.

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