REACH Authorization Process

REACH is a European Union (EU) regulation that was adopted to protect human health and the environment from harmful chemical risks. REACH also promotes the use of alternative testing methods to reduce tests on animals. 

REACH Authorization starts when a Member State or ECHA, at the request of the Commission, proposes a substance to be identified as an SVHC.  

Generally, these include:

• Substances that are carcinogenic, mutagenic, or toxic for reproduction (CMR) category 1A or 1B in accordance with the CLP Regulation.
• Substances that are persistent, bio accumulative, and toxic (PBT) or very persistent and very bio accumulative (vPvB) according to REACH Annex XIII.

• Other case-by-case basis substances that cause an equivalent level of concern as CMR or PBT/vPvB substances.

The SVHC identification process includes a 45-day consultation and the following steps.

The intention to propose a substance for identification as an SVHC is published in the registry of intentions before the proposal is submitted, to inform interested parties in advance of the submission.  

The proposal is prepared according to Annex XV to REACH and includes:

• The data and justification for identifying the substance as an SVHC.
• Information on the uses and possible alternatives to the substance.

After the publication of the proposal, interested parties can comment on it or provide further information during the 45-day consultation. Comments can be made on the properties of the substance, its uses, and alternatives.

If no comments or challenges are received, the substance is included directly in the Candidate List. If comments are received it is evaluated and if the committee reaches a unanimous agreement, the substance is added to the Candidate List. If the committee does not reach a unanimous agreement, the matter is referred to the Commission for further analysis.  

Once a substance is identified as an SVHC, it is included in the Candidate List which means suppliers are responsible to provide the following on each substance:  

• Safety data sheet
• Communication on safe use practices  
• Respond to consumer requests within 45 days.  

• Notify ECHA if their product contains an SVHC in quantities above one ton per producer/importer per year and if the substance is present above the 0.1% (w/w) concentration.