System Engineering / Pressure Equipment

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PED Professional 6

Authorisation

The principle

Authorisation concerns SVHC (substances of very high concern). The aim of the authorisation procedure is to ensure that substances of very high concern will be replaced by suitable alternative substances or technologies and to authorise only those types of production and use where the arising risks are adequately controlled. To continue the production and use of these substances, the companies concerned must apply for an authorisation.

Authorisation applications can be filed by manufacturers, importers and downstream users. Companies can agree to set up a consortium to manage the authorisation procedure together.

Frequently asked questions:
FAQ

Contact:

TÜV SÜD Industrie Service GmbH, München

Authorisation procedures are still unknown territory

Substances of very high concern that meet the criteria for authorisation are published on the "Candidate List" on ECHA website ( (Information obligations concerning substances in articles - SVHCs ). Substances on the "Candidate List" can be included in Annex XIV of the REACH regulation following a specified procedure. Annex XIV also defines the date after which the substance in question, irrespective of the amount, may no longer be imported, otherwise placed on the market or used ("sunset date").

Exemptions from the above rule are only possible if a company has been granted an appropriate authorisation. The authorisations granted may be for one or several uses.

While the production of substances and the placing on the market of articles that include substances listed in Annex XIV are not subject to authorisation, businesses that incorporate a substance included in Annex XIV in an article need an authorisation.

Downstream users that were granted authorisations may only use the substance in accordance with the conditions of an authorisation granted for that use and must also inform ECHA of the use of the authorised substance.

From the applicant's perspective, the authorisation procedure comprises the following steps:
  1. Identify the need for authorisation in good time
    ECHAECHA periodically identifies priority substances from the Candidate List and recommends entries in Annex XIV. Interested parties have the possibility to provide comments. ECHAECHA particularly invites comments on uses or categories of use that are to be exempted from authorisation.
  2. Monitor the route of a substance towards Annex XIV
    The dossiers with the recommendation to include a substance are published and should be analysed for potential business impacts.
  3. Provide comments to these recommendations
    Interested parties can provide comments on these dossiers.
  4. Check the Candidate List at regular intervals
    The list is updated twice annually.
  5. Monitor ECHA's annual proposals for entry in Annex XIV These proposals are also published and should be scrutinised for possible business risks.
  6. Provide your comments on these proposals too
    ECHA accepts comments.
  7. Check whether the substance has been included in Annex XIV
    Relevant changes in the REACH regulation should be monitored with the help of a legislation tracker.
  8. Determine whether you need an authorisation
    Authorisations can be applied by manufacturers, importers or downstream users of the substance. Replacing the substance with a substitute may be an alternative to authorisation.
  9. Decide on the route to authorisation
    Are you the only one aiming for authorisation? Should you file the application alone? Should you set up an authorisation consortium? Should you become a member of an authorisation consortium? Should you buy a "Letter of Access* from the authorisation consortium?
  10. Prepare the authorisation application
    The authorisation application must assess the risks to human health and the environment that form the basis of the substance's classification as an SVHC and its inclusion in Annex XIV. In addition, the applicant must analyse alternative substances and/or technologies and describe possible risks as well as research and development activities. The application may also include a socio-economic analysis.
  11. Submit your authorisation application in good time
    Sunset dates differ from substance to substance. The latest application date will be referenced in Annex XIV.
  12. Submit further information at a later date if necessary
    ECHAECHA may request the applicant to submit further information within a certain deadline.
  13. Provide comments on the evaluation of ECHA
    The approval authorisation is reviewed by various committees. The bundled evaluations of ECHA committees are sent to the applicant.
  14. Influence the final decision
    This can be effected by providing comments as described above.
  15. Implement the decision
    Summaries of the commission decisions, including the authorisation number and the reasons for the decision, are published in the Official Journal of the EU and entered in the public database of ECHA. Applicants are not entitled to a positive decision. The critical factor is the quality of the authorisation application.
  16. Comply with the obligations following authorisation
    The owners of an authorisation and the downstream users must include the authorisation number on the label.
Given this, the authorisation applies directly or indirectly to all companies in the supply chain, including manufacturers, importers, downstream users and retailers.

The Candidate List will be expanded on an ongoing basis. The same applies to the list of substances in Annex XIV of the REACH regulation.

______________________________
* A "Letter of Access" is used to buy the rights to refer to a joint registration dossier

Frequently asked questions:
FAQ

Contact:

TÜV SÜD Industrie Service GmbH, München

Support

Authorisations are granted when the risks arising from the manufacturing or use of the substance can be appropriately controlled. Authorisations can also be granted when socio-economic benefits outweigh the risks to human health or the environment and no alternative substances or technologies are available.

A critical factor for the positive evaluation of the authorisation application by ECHA and the EU commission is the application's quality and completeness, as the mere filing of an application does not entitle the applicant to authorisation.

TÜV SÜD offers the following services to companies that need an authorisation:
  • Implementation of compliance
  • Consulting services throughout all processes
  • Technical support throughout the authorisation procedure
  • Management of authorisation consortia and
  • all other activities that may arise.
Frequently asked questions:
FAQ

Contact:

TÜV SÜD Industrie Service GmbH, München

Candidate List

The process is initiated by an EU Member State or ECHA.

According to the REACH Regulation, Art. 57, substances of very high concern (Information obligations concerning substances in articles - SVHCs) are
  • substances meeting the criteria for classification as carcinogenic, mutagenic or toxic for reproduction (CMR, categories 1A and 1B),
  • substances which are persistent, bioaccumulative and toxic to humans and the ecosystem (PBT),
  • substances which are very persistent and very bioaccumulative (vPvB), or
  • substances which are proposed to be of equivalent concern for human health or the environment for other reasons (e.g. substances having endocrine disrupting properties).
The suggested substances are announced on the website of ECHAECHA in the Registry of Intentions for Annex XV Dossiers = RoI).
On the basis of a dossier in accordance with Annex XV REACH, an EU Member State or ECHAECHA on behalf of the EU Commission can then initiate inclusion in Annex XIV, i.e. in the List of Substances Subject to Authorisation.
Interested parties have the possibility to provide comments on the dossier.

Any comments provided are referenced to the Member States Committee (MSC). If the MSC fails to reach a unanimous agreement, the EU Commission will prepare a draft proposal. A decision will be made in all cases.

If the decision is positive, the substance will be included in the Candidate List.

ECHA publishes the updated Candidate List twice annually on its website.

Frequently asked questions:
FAQ

Contact:

TÜV SÜD Industrie Service GmbH, München

Inclusion

Every year, ECHAECHA proposes certain substances to be included in the Candidate List in Annex XIV. These recommendations are published and interested parties invited to make comments. In addition to the hazardous properties of a substance, the recommendations take into account the array of uses, the production amounts and the environmental properties. If a substance is to be included in the List of Substances Subject to Authorisation, ECHA further defines which uses or manufacturing processes may be exempted from authorisation and after which date the substance may no longer be produced or used without authorisation (sunset date).

ECHA coordinates its proposals with the member states. The draft proposals are then submitted to the EU Commission.

The decision to include a substance in Annex XIV is made by the Commission within the scope of the regulatory procedure described in the REACH regulation Article 133 (3).

Frequently asked questions:
FAQ

Contact:

TÜV SÜD Industrie Service GmbH, München