Short review on legal requirements of REACH Annex XIV when having products listed on the REACH Annex XIV Authorisation List in iChemistry.
General about REACH Authorisation
The authorisation process aims to ensure that substances of very high concern (SVHCs) are progressively replaced by less dangerous substances or technologies where technically and economically feasible alternatives are available.
SVHC are substances with a genuine record of evidence for being hazardous SVHCs are substances with substantial evidence of being hazardous, such as being carcinogenic, toxic for reproduction, or persistent environmental pollutants. These substances are first listed by the European Commission on the Candidate List (which is also searchable in iChemistry), and for these there are also obligations to follow.
From the Candidate List, substances are assessed for the possibility of recommending them for inclusion in the Authorisation List (Annex XIV to REACH). This is a thorough process where alternatives, exemptions, and a timetable for actions are set. After consultation with stakeholders and further processing, the European Commission will finally decide to include a substance in Annex XIV.
In the Authorisation List, there will be information for each substance on:
- Sunset date: The date from which placing on the market and use of a substance is prohibited unless authorisation is granted or its use is exempt from authorisation.
- Latest application date: The date by which applications must be received if the applicant wishes to continue placing the substance on the market or using it after the sunset date.
- Uses exempted from the authorisation requirement, if any.
The Authorisation List can be found here with information on dates, etc.
What will companies have to do?
In general
Companies need to track these substances in their chemical products and certify their responsibilities for each product containing those substances.
REACH allows companies to apply for an authorisation to continue or start using and placing substances included in the Authorisation List (Annex XIV of REACH) on the market. However, this process is cumbersome and expensive. There is a substantial fee just to submit the application, and mandatory surveys and documentation are costly. Additionally, there is no guarantee of granted authorisation, which, if granted, will only be valid for a short period during which alternatives must be investigated.
Remember, the goal is to phase out these substances in all uses that are not absolutely essential.
Applications for authorisation can cover the use of a given substance by the applicant, downstream uses in the supply chain, or both. Typically, a supplier higher up the supply chain applies for the authorisation. If granted, the authorisation permit comes with rules for the use that must be followed, ensuring safe use and minimal exposure.
It's important to note that these rules also apply to the use of these substances throughout the supply chain.
More in detail
If you are a manufacturer, importer, or downstream user, you must have a permit if you want to use or place a substance subject to authorisation on the market. This applies to both pure substances and substances that are part of a mixture.
If the substance is present in a mixture, a permit is usually required if the mixture contains 0.1% by weight or more of the substance. For substances toxic to reproduction, a permit is required if the mixture contains 0.3% by weight or more. In exceptional cases, other concentration limits may apply. Check the applicable limit for your case.
The supplier must notify you of any granted authorisation and the terms you need to follow to use it legally. This could be communicated via an SDS (Safety Data Sheet), but it should preferably be delivered more directly by the supplier. Regardless, you are still responsible for knowing your obligations.
It is advisable to communicate with your supplier about how they handle it. The product and SDS in your system could be outdated or reformulated. The sunset date may be in the future, giving the supplier time to find a solution. Alternatively, the concentration may be below the limit or the use may be exempt. Often, this can be easily checked in the SDS and in the Authorisation decision. However, some suppliers may not even know their obligations.
If you use a substance with a granted authorisation, you must inform the authorities of your use. Downstream users covered by an authorisation granted to an actor higher in their supply chain must notify ECHA of their use. This requirement is based on Article 66 of REACH.
ECHA keeps a register of downstream user notifications and passes this information to the relevant Member State authorities. The register is also searchable on a substance level on ECHAs website.
How iChemistry works to find products with these substances
The system works by reading all declared substances in products using identifiers CAS and EC numbers, making them searchable. This information is then matched with a list of substances covered in Annex XIV, which we retrieve from ECHA and continuously update.
This serves as an indication for you to check your responsibilities as mentioned above.
What you need to do
You need to go through the list of products in the Authorisation List one by one and also check the SDSs to ensure:
- Is the concentration limit above what is permissible without a permit?
- Are there any exemptions for that substance or general exemptions? Scientific research and development could be an exemption, but not general laboratory use. Uses in fuels and mineral oil products under certain conditions are also general exemptions.
- Has the sunset date for the substance passed? If so, it is prohibited without an authorisation, and notification to ECHA must be made. If the product is old, seek new information from the supplier and/or substitute it.
- If the sunset date is in the future, start a dialogue with your supplier and/or plan for substitution.
Feel free to contact Intersolia consultants if you need further help! consulting@intersolia.com