Authorisation Under REACH

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SVHCs and the Authorisation List

The REACH Regulation [1] aims to ensure a high level of protection of human health and the environment from hazardous chemical products. One way that REACH achieves this is to identify and restrict the use of substances of very high concern (SVHCs), which are defined in Article 57 of REACH, and includes:

  • Substances meeting the criteria for classification in following hazard classes: Carc 1A or 1B, Muta 1A or 1B, Repr 1A or 1B. These substances are expected to cause cancer, transmissible genetic defects, or reproductive or developmental effects in humans, and are collectively known as CMRs.
  • Substances meeting the criteria for classification as PBT or vPvB substances. These are long-lasting chemicals that accumulate in animal tissues.
  • Other substances of equivalent level of concern to the above, with endocrine disruptors being specifically mentioned.

SVHCs are subject to the Authorisation process. Industry can only use substances on the Authorisation List (REACH Annex XIV) if the European Chemicals Agency (ECHA) gives dispensation for the specific use and operating conditions, with the aim of encouraging substitution of SVHCs with safer alternatives.

The process for an SVHC to be listed in Annex XIV is complicated and lengthy. The first stage is that suspected SVHCs are identified by Member State authorities in a Community Rolling Action Plan (CoRAP) [2].

Priority substances to be assessed are moved to the Registry of Intentions [3], giving notice to stakeholders that the substance is being evaluated as an SVHC. If, after public consultation, the Member States Committee (MSC) supports further regulatory action, the substance is formally identified as an SVHC and placed on the Candidate List.

Following a further round of consultation with stakeholders and review, ECHA may place the substance on REACH Annex XIV (List of Substances Subject to Authorisation).

To use a substance on Annex XIV, an applicant must demonstrate, through safety assessment and socio-economic analysis, that continuing to use the substance is better than using alternatives.

The processes for the Annex XIV listing, and using a substance subject to authorisation are given below.

From Candidate List to Annex XIV

ECHA prioritises substances from the Candidate List to determine which ones should be included in the Authorisation List as a priority, based on:

  • the substance’s hazards
  • its use pattern, particularly if there is disperse, uncontrolled, or high tonnage use

ECHA proposes a draft entry for the substance in the Authorisation List (REACH Annex XIV), that includes the following details:

  • The Sunset Date, after which marketing and use of a substance is prohibited, unless an authorisation is granted, or an exemption from the authorisation process applies (see below). The Sunset Date is usually 36 to 42 months from inclusion of the Substance in Annex XIV.
  • Latest Application Date by which applications for Authorisation must be received if the applicant wants to continue marketing or using the substance after the Sunset Date. The period between the inclusion of the substance in Annex XIV and the Latest Application Date usually 18 to 24 months, giving 18 months to assess the application before the sunset date.
  • Any uses that are exempted from the authorisation requirement. Specific use exemptions are rare amongst the current Annex XIV substances.

The final decision for inclusion into Annex XIV is made by the European Commission, based on advice from the public consultation, the MSC, and ECHA.  

Applications for authorisation

If a company wants to continue using a substance listed on REACH Annex XIV, then they must apply for an Authorisation for the specific substance and use, unless there are exemptions:

  • Specific exemptions for the use, as given in REACH Annex XIV entry
  • Generic exemptions, ie uses not requiring Authorisation, for example for some intermediate chemicals (ie manufactured and used up in chemical synthesis), substance used for Scientific Research and Development, substances present in mixtures below a certain threshold (usually 0.1wt%), and for some uses regulated separately from REACH (eg cosmetic products and food-contact materials, that already give adequate protections).

There is no exemption from Authorisation for using small quantities of listed substances.

The key elements of the application are:

  • Detailed description of the use, including the function of the substance, the end product, and the market sector.
  • A Chemical Safety Assessment (CSA) and its associated Exposure Scenarios, including operational conditions and risk management measures.
  • Analysis of alternative substances, or combination of substances and technologies, that might be used instead of the Annex XIV substance
  • Socio-economic analysis describing the impacts of not being allowed to use the substance. The positive economic and societal costs of continued use of the substance are balanced against its detrimental effects on health and the environment.

ECHA publish a handy website giving the timeline for submitting applications for Authorisation for particular substances. [4]

The applicant should notify ECHA of their intention to submit an Authorisation request, in order to answer questions and smooth the process.

After submission of the application, and payment of a substantial fee (around €50 000 per use; dossier development is estimated at ca. €100 000), there is further public consultation and assessment, and development of a decision on whether to accept it. 

When an authorisation is granted, an Authorisation number is given, and a date of expiry. The expiry date depends on the strategy for substitution of the substance given in the application, and can be 4 to 12 years. If a company wants to continue using the substance after the Authorisation expires, it must submit an updated application for authorisation at least 18 months before the the expiry date.

The Authorisation number must appear on the label of mixtures used in accordance with the Authorisation.

SVHC substances in articles

An importer cannot import or use a substance on Annex XIV (on its own or in a mixture) after the Sunset Date without an authorisation. This means that an EU-based company cannot manufacture an article (whose function is determined more by shape than chemical composition) using an Annex XIV substance, unless this use is specifically Authorised, with all the associated time and costs.

However, REACH Authorisation does not extend to the presence of the Annex XIV substance in the article itself, which can be imported into the EU without the need for an Authorisation.

The importer of an article containing an Annex XIV substance only has obligation for notification of the article and passing information down the supply chain, as for all substances in the Candidate List.


References

[1] Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH); as amended. [back]

[2] Substance evaluation – CoRAP list; ECHA website. [back]

[3] Registry of SVHC intentions until outcome; ECHA website. [back]

[4] Submission windows; applying for authorisations; ECHA website. [back]

Alchemy Compliance has 22 years of regulatory experience with industrial chemicals, in EU REACH Registration, safety data sheet compilation (EU, US, and beyond), and chemical hazard assessment. Contact us for more information.

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