In the sphere of regulatory compliance and chemical safety, the REACH (Registration, Evaluation, Authorization, and Restriction of Chemicals) framework stands as a crucial pillar. Companies that want authorization under REACH must disclose alternatives for Annex XIV substances they use. This mandate aims to promote transparency and responsible chemical management principles.

The pivotal tool in this endeavor is the Analysis of Alternatives (AoA), an intrinsic component of the authorization application. Contained within the AoA is the pertinent information regarding potential replacements for Annex XIV substances. This vital chemical safety information is now publicly available through the ECHA (European Chemicals Agency) website, providing comprehensive insight into alternatives and improving accessibility.

    • 1. Consultation Number: This numeric identifier, such as xxxx-xx, is emblematic of the application’s sequence within the submission line, coupled with the application’s usage number.
    • 2. Link to Application: A direct hyperlink is provided, connecting users to the application-specific public information page on the ECHA website.
    • 3. Name of Applicant: The corporate entity or entities responsible for submitting the usage application.
    • 4. Substance for Authorization (Full Name): The unabbreviated designation of the substance in question.
    • 5. EC Number: This distinctive seven-digit identifier, articulated in the format xxx-xxx-x, is specifically assigned to substances within the European Union for regulatory purposes.
    • 6. Use Name: A direct reference to the usage sought, aligned with the applicant’s declaration
    • 7. Use Descriptors: The applicant-provided usage descriptors are classified as follows:
  • * TF Technical Function: The functional role of the substance in the requested application under Annex XIV.
  • * SU Sector of Use: The primary industrial sectors pertinent to the requested usage.
  • * PC Product Category: The core product category or categories aligned with the intended usage.
  • * AC Article Category: The principal article category or categories linked to the intended usage.

Additionally, this repository captures the spectrum of alternatives, categorized into three distinct tiers:

    • 1. Most Promising Alternative – Name: This embodies the alternative substance or technology that the applicant identifies as the most viable replacement for the Annex XIV substance. Notably, if a pharmaceutical option is the leading contender, the EC number is indicated; for a substance-based alternative, the CAS (Chemical Abstracts Service) number is provided.
    • 2. Potential Alternative 1 – Name: Within this tier, the applicant outlines alternative materials or technologies that have the potential to replace the Annex XIV chemical in the intended use. The EC number is supplied if the alternative is a material, and the CAS number if it is a substance. Moreover, the applicant’s rationale for not selecting this alternative is encapsulated by technical and economic feasibility, availability, and risk reduction factors. A generalized conclusion sums up the applicant’s overall assessment of this alternative.
    • 3. Potential Alternative 2 and Beyond: While not specified in this text, it’s understood that the table extends to further alternatives, following a similar structure as Potential Alternative 1.

This initiative propels the chemical industry towards sustainable and responsible practices by centralizing information on alternative substances and technologies. Through enhanced access to reliable alternatives, stakeholders can make informed decisions that safeguard human health and the environment.


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