Testing/Service

  • How REACH Works Release time: 2016/7/27 View: 1817
  • How REACH Works

    Registration
    All manufacturers and importers of chemicals must identify and manage risks linked to the substances they produce and market. For substances manufactured or imported in quantities of one tonne or more per year, per company, this must be demonstrated in a registration dossier submitted to the European Chemicals Agency (ECHA).

    This obligation applies to substances on their own and in mixtures. A special registration regime applies for substances in articles (e.g. manufactured goods such as cars, textiles, and electronic chips). However, certain substances are exempted from registration under REACH (see ECHA/Guidance on registration - Chapter 1.6, 700 kB).

    Without registration, substances cannot be manufactured or imported into the EU.

    Links on Registration
    •For companies and SMEs: Leaflet “Chemical safety and your business” (980 kB)
    •ECHA’s website on registration 
    Evaluation
    The European Chemicals Agency (ECHA) may check that registration dossiers comply with the Regulation. It must also evaluate testing proposals to ensure that the assessment of the chemical substances will not result in unnecessary testing, especially on animals, and that adequate information is provided.

    Authorities may also select substances for a broader substance evaluation to further investigate substances of concern.

    More information on the evaluation of chemicals (ECHA)

    Authorisation
    REACH includes an authorisation process to ensure that the risks from substances of very high concern are properly controlled and that those substances are progressively replaced by suitable alternative substances or technologies. Where risks cannot be adequately controlled, the use of those substances may only be authorised where there is an overall benefit for society and there are no suitable alternatives.

    •Substances of very high concern are identified in the REACH 'Candidate list' for eventual inclusion in Annex XIV of the Reach Regulation; 
    •Annex XIV lists the substances subject to authorisation obligations. Once included in that Annex, they cannot be placed on the market or used after a date to be set (the so-called "sunset date") unless the company is granted an authorisation for the specific use;
    •A full list of authorisation decisions    (82 kB) adopted on the basis of Article 64(8) of Regulation (EC) No 1907/2006 (REACH) is publicly available.
    •The list includes reference to the authorisation decisions, as well as to related documentation concerning all applications for authorisation on which an opinion has been adopted by the Committee for Risk Assessment and the Committee for Socio-economic Analysis of ECHA on the basis of Article 64(5) REACH.
    ◦More on authorisation 
    Restrictions
    EU countries or the European Commission (via ECHA) may propose EU-wide restrictions on the manufacture, use, or placing on the market of substances causing an unacceptable risk to human health or the environment.

    Restrictions are designed to manage unacceptable risks that are not addressed by the other REACH processes or by other EU legislation. Restrictions are listed in Annex XVII to REACH.

    •Further information on restrictions and on ECHA website 
    •More on legislation 
    Enforcement
    National authorities are responsible for enforcing REACH through inspections as well as handing out penalties in case of non-compliance. They exchange information and coordinate activities related to enforcement through the Forum for Exchange of Information on Enforcement (the Forum).

    Forum on Enforcement
    A Forum, set up by ECHA, formally brings together national enforcement authorities to:

    •coordinate enforcement activities;
    •promote cooperation, coordination, and the exchange of information between EU countries, the ECHA, and the Commission regarding enforcement;
    •develop coordinated enforcement projects and report on results.
    Since 2007, many projects and documents have been generated.

    •The tasks of the forum are listed in Art.  77.4 of the Reach Regulation      
    •For more, see ECHA 
    Penalties for infringement of REACH
    REACH regulations dictate that EU countries must determine the penalties that would apply to the infringement of REACH provisions and must take all measures necessary to ensure that they are implemented:

    •The penalties must be “effective, proportionate and dissuasive";
    •EU countries have to notify their provisions to the Commission and must also notify any subsequent amendment.
    A comparative study of the penalties that were communicated by EU countries by the first deadline (December 2008) was completed in 2009/2010.

    •Study on REACH penalties (March 2010)   (47 kB)
    •REACH Regulation (Art 126  )
    REACH enforcement authorities
    National authorities are responsible for enforcing REACH. Each EU country has already designated the authority to deal with REACH enforcement.

    For more information, please refer to the authorities in your country. Some information can also be found on the Forum web page of ECHA.

    •Read more on enforcement 
    Enforcement Indicators
    The REACH review communication (February 2013) highlighted that a strong and harmonised approach towards enforcement in the Member States is vital for delivering the objectives of the REACH and CLP Regulations. This is challenging and so Member States are actively cooperating within the Forum to enhance compliance. To ensure more consistent enforcement at EU level, REACH established the Forum for Exchange of Information on Enforcement within ECHA. This Forum is recognised as a useful collaboration platform. The Communication also highlights, among other things, that the Commission will develop enforcement indicators, in liaison with the Forum.

    The Commission contracted a study to develop enforcement indicators. The objective of the study is to propose a set of indicators that can be used to monitor and measure the performance of the enforcement of the REACH and CLP regulations.

    The final report, when available, will be uploaded on this page.

    Fees and charges
    REACH requires that companies pay for certain services delivered by the European Chemicals Agency (ECHA). This includes:

    •registration of chemicals;
    •requests (in a registration submission) that certain information is kept confidential;
    •certain updates of registration submissions;
    •notifications to ECHA of product and process orientated research and development activities, with a view to obtaining an exemption from  registering; and all related extensions to this exemption;
    •applications for an authorisation for chemicals included in Annex XIV of REACH and reviews of authorisations;
    •appeals to the Board of Appeal of the Agency; 
    ◦See the Unofficial consolidation of the REACH Fee Regulation 
    Guidance and helpdesks
    Guidance
    A number of guidance documents can be found on the ECHA website. They aim to support industry and authorities in fulfilling their obligations under REACH and to assist in its implementation.

    •More on guidance documents 
    Helpdesks
    EU countries have established national helpdesks to assist industry in understanding its role and obligations under REACH.

    The ECHA helpdesk also provides support to all companies registering substances.

    In addition, there is a helpdesk on using IUCLID5, the software tool through which companies are required to submit their registrations under REACH. 

    For more information, including the contact details of national helpdesks, please consult the helpdesk section on the ECHA website.