Authorisation

Authorisation is a licensing system of sorts, whereby chemical substances which are included on the Authorisation List (Annex XIV of the REACH Regulation) may not be used or placed on the market for use in the EU, unless an authorisation has been granted for that specific use. The aim of Authorisation is to promote substitution of such hazardous substances with less hazardous substances or technologies.

The first step in the Authorisation process is the identification of a chemical as a Substance of Very High Concern (SVHC) and inclusion on the Candidate List of the European Chemicals Agency (ECHA). SVHCs are identified based on their hazardous effects on human health and/or the environment.

Periodically, ECHA reviews the substances on the Candidate List and recommends some for inclusion in the Authorisation List. The final decision on whether a substance is added to the Authorisation List is taken by the European Commission.

Once a substance is included in the Authorisation List, anyone who wishes to continue to use that substance must submit an authorisation application to ECHA. The final decision on whether to grant the authorisation will be taken by the European Commission.

 

Substances of Very High Concern (SVHCs)

Certain substances which may have serious or irreversible effects on human health or the environment can be identified as Substances of Very High Concern (SVHC). In particular, Article 57 of REACH outlines specific criteria for the identification of SVHCs:

  • Substances classified as carcinogenic, mutagenic or toxic to reproduction (CMRs) category 1A or 1B under CLP
  • Substances that are persistent, bioaccumulative and toxic (PBT) or very persistent and very bioaccumulative (vPvB) to the environment
  • Substances for which there is scientific evidence that they give rise to an equivalent level of concern to CMRs, PBTs or vPvB substances

A Member State or ECHA (on request of the EU Commission) may prepare a proposal to identify a substance as a SVHC when it considers that it meets the above criteria. Such proposals are subject to a public consultation on ECHA’s website. The Member State Committee of ECHA will agree or not on the identification of a chemical as a SVHC. All agreed SVHCs are included on the Candidate List.

 

The Candidate List

The Candidate List is a list of all agreed SVHCs. It is periodically updated and the latest version can be found on the ECHA website. The inclusion of a substance on the Candidate List results in a number of immediate legal obligations on the use of the substance on its own, in mixtures or in articles:

  • Notification: producers and importers of articles containing candidate list substance(s) in a concentration above 0.1% (w/w) and where the quantities of SVHC in the articles is greater than 1 tonne per year must submit a notification to ECHA
  • Information on substances in articles: suppliers of articles which contain candidate list substance(s) in a concentration above 0.1% (w/w) have to provide sufficient information to allow safe use of the article to their customers or, upon request, to a consumer
  • Information on mixtures: suppliers of a mixture not classified as dangerous, but containing at least one substance on the candidate list at a concentration of at least 0.1%, must provide a safety data sheet to recipients on requests
  • Information on substances: Suppliers of a substance that appears on the candidate list must provide a safety data sheet to their customer

 

Addition of substances to the Authorisation List

Periodically ECHA reviews the substances on the Candidate List and prioritises some of them for inclusion in the Authorisation List. The prioritisation by ECHA takes into account the hazardous properties of the substance, use pattern and volume on the EU market. ECHA’s recommendation to add substances to the Authorisation List is subject to a 3 month consultation period where companies and members of the public can submit comments or information.

The final decision on addition of substances to the Authorisation List is taken by the European Commission in collaboration with Member States.

The Authorisation List is periodically updated (currently yearly) and the most up to date version can be found on ECHA’s website.

Information included on the Authorisation List

For each substance included on the Authorisation List two dates are specified:

  • Sunset date - the date after which the placing on the market and/or use of the substance is prohibited unless an authorisation is granted to the user
  • Latest application date (or LAD) - the date by which the authorisation application must be received by ECHA if the applicant wishes to continue to use the substance after the sunset date

In addition, if there are any substance specific uses which are exempted from Authorisation requirements these will also be specified in the Authorisation List.

 

The application for Authorisation

A substance which is included on the Authorisation List cannot be placed on the market or used after its “sunset date” unless an authorisation has been granted. Companies who wish to continue to place on the market and/or use such substances after their sunset date are required to prepare an application for authorisation for their specific use(s) of the substance and submit it to ECHA.

In brief, an application for authorisation should specify:

  • The use(s) for which authorisation is sought
  • A chemical safety report (CSR) covering the risks related to the properties that led to the identification as an SVHC (unless this has already been submitted to ECHA as part of a registration dossier by the applicant
  • An assessment of alternatives
  • A substitution plan, if the conclusion is that there is a feasible alternative
  • For the socio-economic route, a socio economic analysis, along with information that there are not alternatives available.

The preparation of an application for authorisation may require significant effort and resources to complete. Therefore, in advance of preparing an application it is advised to consider whether the substance can be substituted with a less hazardous one. If this is not possible, companies should discuss with their suppliers as to whether the supplier intends to submit an application for authorisation which covers the company’s specific use.

Companies are advised to consult ECHA’s website which provides details on the procedure for preparing an application for authorisation.

 

Exemptions from Authorisation

The scope of Authorisation includes the placing on the market and use(s) of a substance, but not the manufacture of the substance. Therefore, manufacture of a substance is outside the scope of Authorisation.

The Authorisation process does not apply to articles manufactured outside the EU but which are imported into the EU.

There are also a number of specific uses of substances which are exempt from the Authorisation process, mainly as they relate to uses which are already covered by other legislation:

  • Use for scientific research & development
  • Use in medicinal products for human or veterinary use
  • Use in medical devices, but only where the substance has been identified as a SVHC for human health effects
  • Use in food or feeding stuffs
  • Use as on-site isolated intermediate and transported isolated intermediate
  • Use in plant protection products within the scope of Directive 91/414/EEC
  • Use in biocidal products within the scope of Directive 98/8/EC
  • Use as motor fuels covered by Directive 98/70/EC
  • Use as fuels in mobile or fixed combustion plants of mineral oil products and in closed systems
  • Use in cosmetic products within the scope of Directive 76/768/EEC, but only where the substance has been identified as a SVHC for human health effects
  • Use in food contact material within the scope of Regulation (EC) No. 1935/2004, but only where the substance has been identified as a SVHC for human health effects
  • Use in mixtures below certain concentration limits

In addition, if there are any substance specific uses which are exempted from Authorisation requirements these will also be specified in the entry for that substance in the Authorisation List.

 

Authorisation Scenarios

1) I am a supplier and a substance I supply is on the Authorisation List, what do I need to do?

As the aim of Authorisation is to encourage the eventual replacement of SVHCs with less hazardous substances or technologies, in the first instance you should consider whether the substance on the Authorisation List can be substituted with a less hazardous substance or technology.

If you wish to continue to use and/or supply a substance on the Authorisation List for specific use(s) after the sunset date then you need to submit an application for authorisation to ECHA. Further details on how to apply for an authorisation can be found on ECHAs website.

2) I am a downstream user and a substance I use is on the Authorisation List, what do I need to do?

As the aim of Authorisation is to encourage the eventual replacement of SVHCs with less hazardous substances or technologies, in the first instance you should consider whether the substance on the Authorisation List can be substituted with a less hazardous substance or technology.

If you wish to continue to use a substance on the Authorisation List for specific use(s) after the sunset date then an authorisation needs to be in place for your specific use(s). Therefore, you should speak to your supplier to find out if he intends to apply for an authorisation and if he will cover your use. You may need to provide information to your supplier in order for him to confirm whether your use is covered in his authorisation application.

If your current supplier does not intend to apply for an authorisation, or will not cover your specific use(s), then try to find an alternative supplier willing to do it.

Alternatively you could consider submitting your own authorisation application to ECHA which would allow a company immediately above you in the supply chain to supply you with the substance without the supplier needing to have an authorisation in place himself. Further details on how to apply for an authorisation can be found on ECHAs website.

 

Further information

REACH Authorisation Useful Links

The ECHA website contains the most up to date information on all aspects of Authorisation, including the Candidate List, Authorisation List and Guidance for those applying for authorisation. The HSA has produced an information sheet on authorisation.

Any company with any specific questions on authorisation is encouraged to contact our Chemicals helpdesk at chemicals@hsa.ie.